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Background and Purpose: Carotid web (CaW) is an intimal form of fibromuscular dysplasia (FMD) involving the carotid bulb which has been increasingly recognized as a potential cause of recurrent ischemic strokes. It is overlooked as a separate entity and often dismissed if no coexistent signs of classic FMD changes are observed. We aim to evaluate the frequency of classic FMD in high-yield vascular territories in patients with symptomatic CaW., Methods: This was a retrospective analysis of a symptomatic CaW database of 2 comprehensive stroke centers (spanning September 2014-October 2020). The diagnosis of a CaW during a stroke workup was defined as the presence of a shelf-like linear filling defect in the posterior aspect of the carotid bulb on computed tomography angiography in patients with acute ischemic stroke or transient ischemic attack of undetermined cause after a thorough evaluation. Neck computed tomography angiography and renal conventional angiography images were independently evaluated by two readers blinded to the laterality and clinical details to inspect the presence of underlying classic FMD., Results: Sixty-six patients with CaW were identified. Median age was 51 years (interquartile range, 42-57), and 74% were women. All patients had neck computed tomography angiography (allowing for bilateral vertebral and carotid evaluation), whereas 47 patients had additional digital subtraction angiography (which evaluated 47 carotids ipsilateral to the stroke and 10 contralateral carotids). Internal carotid artery classic FMD changes were noted in only 6 out of 66 (9%) in the ipsilateral carotids. No contralateral carotid or vertebral artery classic FMD changes were observed. Renal artery catheter-based angiography was obtained in 16 patients/32 arteries and only 1 patient/2 renal arteries demonstrated classic FMD changes., Conclusions: CaW phenotype is uncommonly associated with classic FMD changes. Coexistent classic FMD does not constitute a useful marker to corroborate or exclude CaW diagnosis.

Background and Purpose- It is unclear which factors predict acute neurological deterioration in patients with large vessel occlusion and mild symptoms. We aim to evaluate the frequency, timing, and potential predictors of acute neurological deterioration ≥4 National Institutes of Health Stroke Scale (NIHSS) points in medically managed patients with large vessel occlusion and mild presentation. Methods- Single-center retrospective study of patients with consecutive minor stroke (defined as NIHSS score of ≤5 on presentation) and large vessel occlusion from January 2014 to December 2017. Primary outcome was acute neurological deterioration ≥4 NIHSS points during the hospitalization. Secondary outcomes included ΔNIHSS (defined as discharge minus admission NIHSS score). Results- Among 1133 patients with acute minor strokes, 122 (10.6%) had visible occlusions on computed tomography angiography/magnetic resonance angiography. Twenty-four (19.7%) patients had ≥4 points deterioration on NIHSS at a median of 3.6 (1-16) hours from arrival. No clinical or radiological predictors of acute neurological deterioration ≥4 NIHSS points were observed on multivariable analysis. Rescue endovascular thrombectomy was performed more often in the ones with acute neurological deterioration ≥4 NIHSS points compared with patients with no deterioration (54% versus 0%; P <0.001). Acute neurological deterioration ≥4 NIHSS points was associated with ΔNIHSS ≥4 points (33% versus 4.9%; P <0.01) and a trend toward lower independence rates at discharge (50% versus 70%; P =0.06) compared with the group with no deterioration. In patients with any degree of neurological worsening, patients who underwent rescue thrombectomy were more likely to be independent at discharge (73% versus 38%; P =0.02) and to have a favorable ΔNIHSS (-2 [-3 to 0] versus 0 [-1 to 6]; P =0.05) compared with the ones not offered rescue thrombectomy. Conclusions- Acute neurological deterioration ≥4 NIHSS points was observed in a fifth of patients with large vessel occlusion and mild symptoms, occurred very early in the hospital course, impacted functional outcomes, and could not be predicted by any of the studied clinical and radiological variables. Rescue thrombectomy was associated with improved clinical outcomes at discharge in patients with neurological deterioration.

Background and Purpose: Carotid webs have been increasingly recognized as a cause of recurrent stroke, but evidence remains scarce. We aim to report the clinical outcomes and first series of carotid stenting in a cohort of patients with strokes from symptomatic carotid webs., Methods: Prospective and consecutive data of patients <65 years old with cryptogenic stroke admitted within September 2014 to May 2017. Carotid web was defined by a shelf-like/linear filling defect in the posterior internal carotid artery bulb by computed tomographic angiography., Results: Twenty-four patients were identified (91.6% strokes/8.4% transient ischemic attacks [TIAs]). Median age was 46 (41-59) years, 61% were female, and 75% were black. Median National Institutes of Health Stroke Scale score was 10.5 (3.0-16.0) and ASPECTS (Alberta Stroke Program Early CT Score) was 8 (7-8). There were no parenchymal hemorrhages, and 96% of patients were independent at 3 months. All webs caused <50% stenosis. In patients with bilateral webs (58%), median ipsilateral web length was larger than contralateral (3.1 [3.0-4.5] mm versus 2.6 [1.85-2.9] mm; P =0.01), respectively. Twenty-nine percent of patients had thrombus superimposed on the symptomatic carotid web. A recurrent stroke/TIA involving the territory of the previously symptomatic web occurred in 7 (32%; 6 strokes/1 TIA) patients: 3 <1 week, 2 1 year of follow-up. Two recurrences occurred on dual antiplatelet therapy, 3 on antiplatelet monotherapy, 1 within 24 hours of thrombolysis, and 1 off antithrombotics. Median follow-up was 12.2 (8.0-18.0) months. Sixteen (66%) patients were stented at a median 12.2 (7.0-18.7) days after stroke with no periprocedural complications. No recurrent strokes/TIAs occurred in stented individuals (median follow-up of 4 [2.4-12.0] months)., Conclusions: Carotid web is associated with high recurrent stroke/TIA risk, despite antithrombotic use, and is amenable to carotid stenting., (© 2017 American Heart Association, Inc.)

Background and Purpose: The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy., Methods: The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017., Results: During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; P =0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; P =0.88) as compared with conventionally consented (n=25). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; P =0.002)., Conclusions: e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes., (© 2017 American Heart Association, Inc.)

Background and Purpose: Accurate long-term outcome prognostication in basilar artery occlusion strokes may guide clinical management in the subacute stage. We determine the prognostic value of the follow-up neurological examination using the National Institutes of Health stroke scale (NIHSS) and identify 24- to 48-hour NIHSS risk categories in basilar artery occlusion patients., Methods: Participants of an observational registry of radiologically confirmed acute basilar artery occlusion (BASICS [Basilar Artery International Cooperation Study]) with prospectively collected 24- to 48-hour NIHSS and 1-month modified Rankin scale scores were included. Uni- and multivariable modeling were performed to identify independent predictors of poor outcome. Predictive powers of baseline and 24- to 48-hour NIHSS for poor outcome (modified Rankin scale, 4-6) and 1-month mortality were determined by receiver operating characteristic analyses. Classification and regression tree analysis was performed to identify risk groups., Results: Three hundred seventy-six of 619 BASICS participants were included, of whom 65.4% had poor outcome. In multivariable analyses, 24- to 48-hour NIHSS (odds ratio=1.28 [1.21-1.35]), history of minor stroke (odds ratio=2.64 [1.04-6.74], time to treatment >6 hours (odds ratio=3.07 [1.35-6.99]), and age (odds ratio=1.02 [0.99-1.04]) were retained in the final model as predictors of poor outcome. Prognostic power of 24- to 48-hour NIHSS was higher than baseline NIHSS for 1-month poor outcome (area under the curve, 0.92 versus 0.75) and mortality (area under the curve, 0.85 versus 0.72). Classification and regression tree analysis identified five 24- to 48-hour NIHSS risk categories with poor outcome rates of 9.4% (NIHSS 0-4), 36% (NIHSS 5-11), 84.3% (NIHSS 12-22), 96.1% (NIHSS 23-27), and 100% (NIHSS≥28)., Conclusions: Twenty-four- to 48-hour NIHSS accurately predicts 1-month poor outcome and mortality and represents a clinically valuable prognostic tool for the care of basilar artery occlusion patients., (© 2016 American Heart Association, Inc.)

Background and Purpose: The semiquantitative noncontrast CT Alberta Stroke Program Early CT Score (ASPECTS) and RAPID automated computed tomography (CT) perfusion (CTP) ischemic core volumetric measurements have been used to quantify infarct extent. We aim to determine the correlation between ASPECTS and CTP ischemic core, evaluate the variability of core volumes within ASPECTS strata, and assess the strength of their association with clinical outcomes., Methods: Review of a prospective, single-center database of consecutive thrombectomies of middle cerebral or intracranial internal carotid artery occlusions with pretreatment CTP between September 2010 and September 2015. CTP was processed with RAPID software to identify ischemic core (relative cerebral blood flow<30% of normal tissue)., Results: Three hundred and thirty-two patients fulfilled inclusion criteria. Median age was 66 years (55-75), median ASPECTS was 8 (7-9), whereas median CTP ischemic core was 11 cc (2-27). Median time from last normal to groin puncture was 5.8 hours (3.9-8.8), and 90-day modified Rankin scale score 0 to 2 was observed in 54%. The correlation between CTP ischemic core and ASPECTS was fair (R=-0.36; P<0.01). Twenty-six patients (8%) had ASPECTS <6 and CTP core ≤50 cc (37% had modified Rankin scale score 0-2, whereas 29% were deceased at 90 days). Conversely, 27 patients (8%) had CTP core >50 cc and ASPECTS ≥6 (29% had modified Rankin scale 0-2, whereas 21% were deceased at 90 days). Moderate correlations between ASPECTS and final infarct volume (R=-0.42; P<0.01) and between CTP ischemic core and final infarct volume (R=0.50; P<0.01) were observed; coefficients were not significantly influenced by the time from stroke onset to presentation. Multivariable regression indicated ASPECTS ≥6 (odds ratio 4.10; 95% confidence interval, 1.47-11.46; P=0.01) and CTP core ≤50 cc (odds ratio 3.86; 95% confidence interval, 1.22-12.15; P=0.02) independently and comparably predictive of good outcome., Conclusions: There is wide variability of CTP-derived core volumes within ASPECTS strata. Patient selection may be affected by the imaging selection method., (© 2016 American Heart Association, Inc.)

Background and Purpose: Acute ischemic stroke patients with large volumes of severe hypoperfusion (Tmax>10 s>100 mL) on magnetic resonance imaging have a higher likelihood of intracranial hemorrhage and poor outcomes after reperfusion. We aim to evaluate the impact of the extent of Tmax>10 s CTP lesions in patients undergoing successful treatment., Methods: Retrospective database review of endovascular acute ischemic stroke treatment between September 2010 and March 2015 for patients with anterior circulation occlusions with baseline RAPID CTP and full reperfusion (mTICI 3). The primary outcome was the impact of the Tmax>10 s lesion spectrum on infarct growth. Secondary safety and efficacy outcomes included parenchymal hematomas and good clinical outcomes (90-day modified Rankin Scale score, 0-2)., Results: Of 684 treated patients, 113 patients fit the inclusion criteria. Tmax>10 s>100 mL patients (n=37) had significantly higher baseline National Institutes of Health Stroke Scale (20.7±3.8 versus 17.0±5.9; P<0.01), more internal carotid artery terminus occlusions (29% versus 9%; P=0.02), and larger baseline (38.6±29.6 versus 11.7±15.8 mL; P<0.01) and final (60.7±60.0 versus 29.4±33.9 mL; P<0.01) infarct volumes when compared with patients without Tmax>10 s>100 mL (n=76); however, the 2 groups were otherwise well balanced. There were no significant differences in infarct growth (22.1±51.6 versus 17.8±32.4 mL; P=0.78), severe intracranial hemorrhage (PH2: 2% versus 4%; P=0.73), good outcomes (90-day mRS score, 0-2: 56% versus 59%; P=0.83), or 90-day mortality (16% versus 7%; P=0.28). On multivariate analysis, only baseline National Institutes of Health Stroke Scale (odds ratio, 1.19; 95% confidence interval, 1.06-1.34; P<0.01) and baseline infarct core volume (odds ratio, 1.05; 95% confidence interval, 1.02-1.08; P<0.01) were independently associated with Tmax>10 s>100 mL. There was no association between Tmax>10 s>100 mL with any PH, good outcome, or infarct growth., Conclusions: In the setting of limited baseline ischemic cores, large Tmax>10 s lesions on computed tomographic perfusion do not seem to be associated with a higher risk of parenchymal hematomas and do not preclude good outcomes in patients undergoing endovascular reperfusion with contemporary technology., (© 2015 American Heart Association, Inc.)

Background and Purpose: The role of antiepileptic drug (AED) prophylaxis after intracerebral hemorrhage (ICH) remains unclear. This analysis describes prevalence of prophylactic AED use, as directed by treating clinicians, in a prospective ICH cohort and tests the hypothesis that it is associated with poor outcome., Methods: Analysis included 744 patients with ICH enrolled in the Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study before November 2012. Baseline clinical characteristics and AED use were recorded in standardized fashion. ICH location and volume were recorded from baseline neuroimaging. We analyzed differences in patient characteristics by AED prophylaxis, and we used logistic regression to test whether AED prophylaxis was associated with poor outcome. The primary outcome was 3-month modified Rankin Scale score, with 4 to 6 considered poor outcome., Results: AEDs were used for prophylaxis in 289 (39%) of the 744 subjects; of these, levetiracetam was used in 89%. Patients with lobar ICH, craniotomy, or larger hematomas were more likely to receive prophlyaxis. Although prophylactic AED use was associated with poor outcome in an unadjusted model (odds ratio, 1.40; 95% confidence interval, 1.04-1.88; P=0.03), this association was no longer significant after adjusting for clinical and demographic characteristics (odds ratio, 1.11; 95% confidence interval, 0.74-1.65; P=0.62)., Conclusions: We found no evidence that AED use (predominantly levetiracetam) is independently associated with poor outcome. A prospective study is required to assess for a more modest effect of AED use on outcome after ICH., (© 2015 American Heart Association, Inc.)

Background and Purpose: Oral anticoagulation (OAC) plays a major role in atrial fibrillation stroke prevention but represents a contraindication to intravenous tissue-type plasminogen activator. Intra-arterial therapy remains a potential reperfusion strategy in these patients; however, supporting data are scarce., Methods: Retrospective analysis of prospectively collected consecutive intra-arterial therapies from October 2010 to March 2015 comparing OAC (vitamin-K antagonists and novel oral anticoagulants) versus normal hemostasis versus intravenous tissue-type plasminogen activator patients. Primary safety end point is parenchymal hematoma. Secondary safety end point is 90-day mortality. Efficacy end points are successful reperfusion (modified Thrombolysis in Cerebral Infarction, 2b-3) and good outcome (90-day modified Rankin Scale score of 0-2). Logistic regression for predictors of parenchymal hematoma was performed., Results: A total of 604 patients were qualified for the study. Baseline and outcomes variables were overall similar for vitamin-K antagonists (n=29) and novel oral anticoagulants (n=17) patients. When compared with normal hemostasis (n=265) and intravenous tissue-type plasminogen activator (n=297), OAC (n=46) patients were older and had more comorbidities. There were no statistically significant differences in the rates of parenchymal hematoma (8% versus 5%; P=0.42), 90-day modified Rankin Scale score of 0 to 2 (30% versus 40%; P=0.26), and 90-day mortality (32% versus 26%; P=0.46) among OAC and normal hemostasis patients. Similarly, there were no significant differences between OAC and intravenous tissue-type plasminogen activator patients in terms of parenchymal hematoma (8% versus 4%; P=0.16), 90-day modified Rankin Scale score of 0 to 2 (30% versus 43%; P=0.13), and 90-day mortality (32% versus 22%; P=0.18). The use of OAC was not associated with the occurrence of parenchymal hematoma on multivariate logistic regression analysis., Conclusions: Intra-arterial therapy seems to be safe in patients taking OACs; however, our study showed a nonsignificant increase in hemorrhage and mortality with a nonsignificant decrease in good outcomes in comparison with non-OAC patients. Although these nominal differences may have been related to older age and more comorbidities in the OAC group, larger studies are needed to confirm our findings given our limited sample size., (© 2015 American Heart Association, Inc.)

Background and Purpose: Diffusion-weighted imaging (DWI) Alberta Stroke Program Early CT Score (ASPECTS), a surrogate of infarct volume, predicts outcome in anterior large vessel occlusion strokes. We aim to determine whether topological information captured by DWI ASPECTS contributes additional prognostic value., Methods: Adults with intracranial internal carotid artery, M1 or M2 middle carotid artery occlusions who underwent endovascular therapy were included. The primary outcome measure was poor clinical outcome (3-month modified Rankin Scale score, 3-6). Prognostic value of the 10 DWI ASPECTS regions in predicting poor outcome was determined by multivariable logistic regression, controlling for final infarct volume, age, and laterality., Results: Two hundred and thirteen patients (mean age, 66.1±14.5 years; median National Institutes of Health Stroke Scale, 15) were included. Inter-rater reliability was good for DWI ASPECTS (deep regions, κ=0.72; cortical regions, κ=0.63). All DWI ASPECTS regions with the exception of the putamen were significant predictors (P<0.05) of poor outcome in univariate analyses. Statistical collinearity among ASPECTS regions was not observed. Using penalized multivariable logistic regression, only M4 (odds ratio, 2.82; 95% confidence interval, 1.39-5.76) and M6 (odds ratio, 2.45; 95% confidence interval, 1.15-5.3) involvement were associated with poor outcome. M6 involvement independently predicted poor outcome in right hemispheric strokes (odds ratio, 5.8; 95% confidence interval, 1.9-20.3), whereas M4 (odds ratio, 4.3; 95% confidence interval, 1.3-15.0) involvement predicted poor outcome in left hemispheric strokes adjusting for infarct volume. Topologic information modestly improved the predictive ability of a prognostic score that incorporates age, infarct volume, and hemorrhagic transformation., Conclusions: Involvement of the right parieto-occipital (M6) and left superior frontal (M4) regions affect clinical outcome in anterior large vessel occlusions over and above the effect of infarct volume and should be considered during prognostication., (© 2015 American Heart Association, Inc.)

Background and Purpose: Sulcal effacement with preserved underlying gray-white matter junction (isolated sulcal effacement [ISE]) in acute ischemic stroke may not represent irreversible parenchymal injury. We aimed to evaluate the frequency and significance of ISE in patients with large vessel occlusion acute ischemic stroke., Methods: Consecutive acute ischemic stroke patients with middle cerebral artery M1 or internal carotid artery terminus occlusions who underwent computed tomography angiogram/perfusion followed by intra-arterial therapy were screened for ISE., Results: Out of the 568 patients who underwent intra-arterial therapy between March 2011 and September 2014, 108 fulfilled inclusion criteria. ISE was present in 8 (7.4%) patients (age 55.7±10.5 years, 6 female, baseline National Institutes of Health Stroke Scale 16.1±3.8, 5 middle cerebral artery-M1, and 3 internal carotid artery terminus occlusions). Computed tomography angiogram revealed engorged/dilated leptomeningeal vessels obliterating the sulci within the areas of effacement, whereas computed tomography perfusion indicated normal-to-increased cerebral blood volume and prolonged Tmax in all patients. Modified treatment in cerebral ischemia (mTICI) 2b-3 reperfusion was achieved in all patients. Follow-up imaging confirmed no infarct in the ISE area in all patients, and 5 (62%) had modified Rankin Scale 0 to 2 at 3 months., Conclusions: Sulcal effacement with preserved gray-white delineation is occasionally visualized in patients with proximal occlusion strokes, relates to robust leptomeningeal collaterals, and indicates preserved underlying parenchyma. ISE should not be used to exclude patients from thrombectomy., (© 2015 American Heart Association, Inc.)

Background and Purpose: Prognostication tools that predict good outcome in patients with anterior circulation large vessel occlusions after endovascular therapy are lacking. We aim to develop a tool that incorporates clinical and imaging data to predict outcomes after endovascular therapy., Methods: In a derivation cohort of anterior circulation large vessel occlusion stroke patients treated with endovascular therapy within 8 hours from time last seen well (n=247), we performed logistic regression to identify independent predictors of good outcome (90-day modified Rankin Scale, 0-2). Factors were weighted based on β-coefficients to derive the Pittsburgh Outcomes After Stroke Thrombectomy (POST) score. POST was validated in an institutional endovascular database (University of Pittsburgh Medical Center, n=393) and the Diffusion-Weighted Imaging Evaluation for Understanding Stroke Evolution Study-2 (DEFUSE-2) data set (n=105), as well as in patients treated beyond 8 hours (n=194) and in octogenarians (n=111)., Results: In the derivation cohort, independent predictors (P<0.1) of good outcome included 24- to 72-hour final infarct volume (in cm(3), P<0.001), age (years, P<0.001), and parenchymal hematoma types 1 and 2 (H, P=0.01). POST was calculated as age+0.5×final infarct volume+15×H. Patients with POST score <60 had a 91% chance of good outcome compared with 4% with POST score ≥120. POST accurately predicted good outcomes in the derivation (area under the curve [AUC]=0.85) and validation cohorts (University of Pittsburgh Medical Center, AUC=0.81; DEFUSE-2, AUC=0.86), as well as in patients treated beyond 8 hours (AUC, 0.85) and octogenarians (AUC=0.76). POST had better predictive accuracy for good and poor outcome than the ischemic stroke predictive risk score (iSCORE)., Conclusions: POST score is a validated predictor of outcome in patients with anterior circulation large vessel occlusions after endovascular therapy., (© 2014 American Heart Association, Inc.)

Background and Purpose: The proteome of newly synthesized proteins (nascent proteome) in peripheral blood mononuclear cells (PBMCs) can be a novel source of stroke biomarkers. Changes in the PBMC nascent proteome after stroke reflect the dynamic response-in-action not detectable in the total proteome (all existing proteins) in blood. Here, we test the application of nascent proteomics as a novel approach for stroke biomarker discovery., Methods: The PBMC nascent proteome in human blood was determined by metabolic labeling of fresh PBMC cultures with azidohomoalanine (an azide-containing methionine surrogate), followed by mass spectrometry detection and quantification of azidohomoalanine-labeled proteins. The PBMC nascent and total proteomes were compared between patients with stroke and matched controls., Results: Both PBMC nascent and total proteomes showed differences between stroke patients and controls. Results of hierarchical clustering analysis of proteomic data revealed greater changes in the nascent than in the total PBMC proteomes, supporting the usefulness of the PBMC nascent proteome as a novel source of stroke biomarkers., Conclusions: Nascent proteomes in PBMC can be a novel source for biomarker discovery in human stroke.

Background and Purpose: Epidemiological studies of intracerebral hemorrhage (ICH) have consistently demonstrated variation in incidence, location, age at presentation, and outcomes among non-Hispanic white, black, and Hispanic populations. We report here the design and methods for this large, prospective, multi-center case-control study of ICH., Methods: The Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study is a multi-center, prospective case-control study of ICH. Cases are identified by hot-pursuit and enrolled using standard phenotype and risk factor information and include neuroimaging and blood sample collection. Controls are centrally identified by random digit dialing to match cases by age (±5 years), race, ethnicity, sex, and metropolitan region., Results: As of March 22, 2013, 1655 cases of ICH had been recruited into the study, which is 101.5% of the target for that date, and 851 controls had been recruited, which is 67.2% of the target for that date (1267 controls) for a total of 2506 subjects, which is 86.5% of the target for that date (2897 subjects). Of the 1655 cases enrolled, 1640 cases had the case interview entered into the database, of which 628 (38%) were non-Hispanic black, 458 (28%) were non-Hispanic white, and 554 (34%) were Hispanic. Of the 1197 cases with imaging submitted, 876 (73.2%) had a 24 hour follow-up CT available. In addition to CT imaging, 607 cases have had MRI evaluation., Conclusions: The ERICH study is a large, case-control study of ICH with particular emphasis on recruitment of minority populations for the identification of genetic and epidemiological risk factors for ICH and outcomes after ICH.

Background and Purpose: Quality of care may be influenced by patient and hospital factors. Our goal was to use multilevel modeling to identify patient-level and hospital-level determinants of the quality of acute stroke care in a stroke registry., Methods: During 2001 to 2002, data were collected for 4897 ischemic stroke and TIA admissions at 96 hospitals from 4 prototypes of the Paul Coverdell National Acute Stroke Registry. Duration of data collection varied between prototypes (range, 2-6 months). Compliance with 8 performance measures (recombinant tissue plasminogen activator treatment, antithrombotics < 24 hours, deep venous thrombosis prophylaxis, lipid testing, dysphagia screening, discharge antithrombotics, discharge anticoagulants, smoking cessation) was summarized in a composite opportunity score defined as the proportion of all needed care given. Multilevel linear regression analyses with hospital specified as a random effect were conducted., Results: The average hospital composite score was 0.627. Hospitals accounted for a significant amount of variability (intraclass correlation = 0.18). Bed size was the only significant hospital-level variable; the mean composite score was 11% lower in small hospitals (≤ 145 beds) compared with large hospitals (≥ 500 beds). Significant patient-level variables included age, race, ambulatory status documentation, and neurologist involvement. However, these factors explained < 2.0% of the variability in care at the patient level., Conclusions: Multilevel modeling of registry data can help identify the relative importance of hospital-level and patient-level factors. Hospital-level factors accounted for 18% of total variation in the quality of care. Although the majority of variability in care occurred at the patient level, the model was able to explain only a small proportion.

Background and Purpose: Public knowledge of stroke warning signs and risk factors is poor, especially in higher risk groups such as blacks. We sought to design a creative new way to educate black women by working through local beauty salons and measuring the results of the intervention., Methods: Thirty black beauticians were educated about stroke warning signs and risk factors in 2 large urban areas in the US. The beauticians then educated their clientele during appointments. Stroke knowledge gained was measured via de-identified pre- and post-intervention (at 6 weeks and 5 months) surveys that included open-ended questions. Stroke warning signs were taught using the "FAST" (Face, Arm, Speech, Time) method., Results: There were 383 completed baseline surveys, and 318 surveys were completed at 5 months. Of the 383 women, 78% were <60 years old, 69% had some college education, 41% had hypertension, and 12% had diabetes. The percentage of women who knew 3 warning signs significantly improved from the baseline survey (40.7%) to the final survey (50.6%), and similar improvements in knowledge were seen in both study regions. There was no improvement in knowledge of 3 risk factors (16.5% versus 18.2%). After our educational intervention, 94% knew to call 911 for stroke symptoms, an 8% improvement over baseline (P=0.002)., Conclusions: Despite the challenges of community-based research encountered within our project, we found that stroke education in the beauty shop significantly improved knowledge regarding stroke warning signs and calling 911 among a group of black women. This improvement in knowledge was sustained for at least 5 months. Knowledge of stroke risk factors, however, did not improve. The use of the beauty shop as an educational site is a novel approach to stroke education for women that can be practically applied in the community. Education regarding stroke risk factors remains a challenge that warrants further study.

Background and Purpose: The Paul Coverdell National Acute Stroke Registry is being developed to improve the quality of acute stroke care. This article describes key features of acute stroke care from 4 prototype registries in Georgia (Ga), Massachusetts (Mass), Michigan (Mich), and Ohio., Methods: Each prototype developed its own sampling scheme to obtain a representative sample of hospitals. Acute stroke admissions were identified using prospective (Mass, Mich) or retrospective (Ga, Ohio) methods. All prototypes used a common set of case definitions and data elements. Weighted site-specific frequencies were generated for each outcome., Results: A total of 6867 admissions from 98 hospitals were included; the majority were ischemic strokes (range, 52% to 70%) with transient ischemic attack and intracerebral hemorrhage comprising the bulk of the remainder. Between 19% and 26% of admissions were younger than age 60 years, and between 52% and 58% were female. Black subjects varied from 7.1% (Mich) to 30.6% (Ga). Between 20% and 25% of admissions arrived at the emergency department within 3 hours of onset. Treatment with recombinant tissue plasminogen activator (rtPA) was administered to between 3.0% (Ga) and 8.5% (Mass) of ischemic stroke admissions. Of 118 subjects treated with intravenous rtPA, <20% received it within 60 minutes of arrival. Compliance with secondary prevention practices was poorest for smoking cessation counseling and best for antithrombotics., Conclusions: A minority of acute stroke patients are treated according to established guidelines. Quality improvement interventions, targeted primarily at the health care systems level, are needed to improve acute stroke care in the United States.

Background and Purpose: Little is known in regard to cerebral arterial reocclusion after successful thrombolysis. In the absence of arteriographic information, the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial investigators prospectively identified clinical deterioration following improvement (DFI) as a possible surrogate marker of cerebral arterial reocclusion after rt-PA-induced recanalization. Also, we identified any significant clinical deterioration (CD) even if not preceded by improvement. This observational analysis was designed to determine the incidence of DFI and CD in each treatment group, to identify baseline or posttreatment variables predictive of DFI or CD, and to determine any relationship between DFI, CD, and clinical outcome., Methods: DFI was defined as any 2-point deterioration on the NIH Stroke Scale after an initial 2-point improvement after treatment. CD was defined as any 4-point worsening after treatment compared with baseline. All data were collected prospectively by investigators blinded to treatment allocation. A noncontrast brain CT was mandated when a 2-point deterioration occurred. All cases were validated by a central review committee., Results: DFI was identified in 81 of the 624 patients (13%); 44 were treated with rt-PA and 37 were treated with placebo (P:=0.48). DFI occurred more often in patients with a higher baseline NIH Stroke Scale score. CD within the first 24 hours occurred in 98 patients (16% of all patients); 43 were given rt-PA and 55 were given placebo (P:=0.19). Baseline variables associated with CD included a less frequent use of prestroke aspirin and a higher incidence of early CT changes of edema or mass effect or dense middle cerebral artery sign. Patients with CD had higher rates of increased serum glucose and fibrin degradation products, and they also had higher rates of symptomatic intracranial hemorrhage and death. Patients who experienced either DFI or CD were less likely to have a 3-month favorable outcome., Conclusions: We found no association between DFI, CD, and rt-PA treatment, and no clinical evidence to suggest reocclusion. Deterioration was strongly associated with stroke severity and poor outcome and was less frequent in patients whose stroke occurred while they were on aspirin.

Background and Purpose: We sought to identify the most powerful binary measures of the treatment effect of tissue plasminogen activator (tPA) in the National Institute of Neurological Disorders and Stroke (NINDS) rTPA Stroke Trial., Methods: Using the Classification and Regression Tree (CART) algorithm, we evaluated binary cut points and combination of binary cut points with the 4 clinical scales and head CT imaging measures in the NINDS tPA Stroke Trial at 4 times after treatment: 2 hours, 24 hours, 7 to 10 days, and 3 months. The first analysis focused on detecting evidence of "early activity" of tPA with the use of outcome measures derived from the 2-hour and 24-hour clinical and radiographic measures. The second analysis focused on longer-term outcome and "efficacy" and used outcome measures derived from 7- to 10-day and 3-month measures. After identifying the cut points with the ability to classify patients into the tPA and placebo groups using part I data from the trial, we then used data from part II of the trial to validate the results., Results: Of the 5 most powerful outcome measures for early activity of tPA, 4 involved the National Institutes of Health Stroke Scale (NIHSS) score at 24 hours or changes in the NIHSS score from baseline to 24 hours. The best overall single outcome measure was an NIHSS score

Background and Purpose: The purpose of this study was to test the feasibility, efficacy, and safety of combined intravenous (IV) and local intra-arterial (IA) recombinant tissue plasminogen activator (r-TPA) therapy for stroke within 3 hours of onset of symptoms., Methods: This was a double-blind, randomized, placebo-controlled multi-center Phase I study of IV r-TPA or IV placebo followed by immediate cerebral arteriography and local IA administration of r-TPA by means of a microcatheter. Treatment activity was assessed by improvement on the National Institutes of Health Stroke Scale Score (NIHSSS) at 7 to 10 days. The Barthel Index, modified Rankin Scale, and the Glasgow Outcome Scale measured 3-month functional outcome. Arterial recanalization rates and their relation to total r-TPA dose and time to lysis were measured. Rates of life-threatening bleeding, intracerebral hemorrhage (ICH), or other bleeding complications assessed safety., Results: Thirty-five patients were randomly assigned, 17 into the IV/IA group and 18 into the placebo/IA group. There was no difference in the 7- to 10-day or the 3-month outcomes, although there were more deaths in the IV/IA group. Clot was found in 22 of 34 patients. Recanalization was better (P=0. 03) in the IV/IA group with TIMI 3 flow in 6 of 11 IV/IA patients versus 1 of 10 placebo/IA patients and correlated to the total dose of r-TPA (P=0.05). There was no difference in the median treatment intervals from time of onset to IV treatment (2.6 vs 2.7 hours), arteriography (3.3 vs 3.0 hours), or clot lysis (6.3 vs 5.7 hours) between the IV/IA and placebo/IA groups, respectively. A direct relation between NIHSSS and the likelihood of the presence of a clot was identified. Eight ICHs occurred; all were hemorrhagic infarctions. There were no parenchymal hematomas. Symptomatic ICH within 24 hours occurred in 1 placebo/IA patient only. Beyond 24 hours, symptomatic ICH occurred in 2 IV/IA patients only. Life-threatening bleeding complications occurred in 2 patients, both in the IV/IA group. Moderate to severe bleeding complications occurred in 2 IV/IA patients and 1 placebo/IA patient., Conclusions: This pilot study demonstrates combined IV/IA treatment is feasible and provides better recanalization, although it was not associated with improved clinical outcomes. The presence of thrombus on initial arteriography was directly related to the baseline NIHSSS. This approach is technically feasible. The numbers of symptomatic ICH were similar between the 2 groups, which suggests that this approach may be safe. Further study is needed to determine the safety and effectiveness of this new method of treatment. Such studies should address not only efficacy and safety but also the cost-benefit ratio and quality of life, given the major investment in time, personnel, and equipment required by combined IV and IA techniques.

Background and Purpose: Ischemic changes identified on CT scans performed in the first few hours after stroke onset, which are thought to possibly represent early cytotoxic edema and development of irreversible injury, may have important implications for subsequent treatment. However, insecurity and conflicting data exist over the ability of clinicians to correctly recognize and interpret these changes. We performed a detailed review of selected baseline CT scans from the NINDS rt-PA Stroke Trial to test agreement among experienced stroke specialists and other physicians on the presence of early CT ischemic changes., Methods: Seventy baseline CT scans from the NINDS Stroke Trial were read and classified for the presence or absence of various early findings of ischemia by 16 individuals, including NINDS trial investigators, other neurologists, other emergency medicine physicians, and radiology or stroke fellows. CT scans included normal scans and scans from patients who later developed symptomatic intracranial hemorrhage, as well as scans on which the NINDS rt-PA Stroke Trial neuroradiologist identified clear-cut early CT changes. For each CT finding, kappa-statistics were used to assess the proportion of agreement beyond chance., Results: kappa-Values (95% confidence interval [CI]) ranged from 0.20 (-0.20, 0.61) (fair agreement) to 0.41 (0.37, 0.45) (moderate agreement) among the 16 viewers, and the kappa-value was only 0.39 (0.29, 0.49) (fair) in answer to the question "do early CT changes involve more than one third of the MCA [middle cerebral artery] territory?" There was substantial variability within each specialty group and between groups. kappa-Values were only fair to moderate even among physicians experienced in selecting and treating acute stroke patients with rtPA. Observed agreement ranged from 68% to 85%. Physicians agreed on the finding of early CT changes involving >33% of the MCA territory 77% of the time, although the kappa-value of 0.39 suggested only moderate agreement beyond chance., Conclusions: There is considerable lack of agreement, even among experienced clinicians, in recognizing and quantifying early CT changes. Improved methods of recognizing and quantifying early ischemic brain damage are needed.

Background and Purpose: We examined the frequency, course, and treatment of hypertension in the NINDS rt-PA Stroke Trial., Methods: Blood pressure (BP) was measured at the time of admission, at randomization, and then 36 times during the first 24 hours after randomization. Patients with a systolic BP of >185 mm Hg and a diastolic BP of >110 mm Hg at admission were defined as hypertensive before randomization, and those with a systolic BP of >180 mm Hg or a diastolic BP of >105 mm Hg within the first 24 hours after randomization were defined as hypertensive after randomization. Standardized clinical assessments were conducted at 24 hours and at 3 months. Post hoc analyses were conducted to evaluate the association of antihypertensive therapy with clinical outcomes., Results: Of the 624 patients, 121(19%) had hypertension on admission and 372 (60%) had hypertension in the 24 hours after randomization. The use of antihypertensive therapy before randomization (tPA 9%, placebo 9%) and after randomization (tPA 24%, placebo 29%) was similar between placebo- and tPA-treated patients. No adverse effects of prerandomization antihypertensive therapy on 3-month favorable outcome were detected for either the placebo- or tPA-treated groups. For placebo patients with hypertension in the 24 hours after randomization, clinical outcome measures were similar for those patients who did and did not receive antihypertensive therapy after randomization (P > or = 0.26); antihypertensive therapy was not associated with declines in BP (P = 0.44) or with abrupt declines (P = 0.14). Those tPA patients who were hypertensive after randomization and received antihypertensive therapy were less likely to have a favorable outcome at 3 months (P < 0.01) than those who were hypertensive and did not receive antihypertensive therapy., Conclusions: The frequency of hypertension and the use of antihypertensive therapy were similar between the tPA and placebo groups in the NINDS rt-PA Stroke Trial. In the placebo group, antihypertensive therapy was not associated with less favorable outcomes at 3 months; postrandomization antihypertensive therapy was associated with less favorable outcomes for the tPA patients who were hypertensive. However, because of the nonrandomized use of antihypertensive therapy and the many post hoc comparisons leading to type 1 errors, the significance of this observation is unclear. Careful attention to BP and gentle management remain warranted for stroke patients treated with tPA.

Background and Purpose: Blacks are at a higher risk for intracerebral hemorrhage (ICH) than whites; however, few data are available regarding the demographic and clinical characteristics of ICH among blacks., Methods: We determined the frequency of risk factors, etiologic subtypes, and outcome among consecutive black patients admitted with nontraumatic ICH to a university-affiliated public hospital., Results: The most common risk factors in the 403 black patients with ICH were preexisting hypertension (77%), alcohol use (40%), and smoking (30%). Among the 91 nonhypertensive patients, 21 (23%) were diagnosed with hypertension after onset. Compared with women, men had a younger age of onset (54 versus 60 years; P < .001) and higher frequency of alcohol use (54% versus 22%; P < .001) and smoking (39% versus 17%; P < .001). ICH secondary to hypertension (n = 311) and of undetermined etiology (n = 73) were the most common subtypes in blacks. Patients aged 65 years and older (compared with those aged 15 to 44 years; P = .001) and women (compared with men; P = .02) were more likely to be dependent at discharge., Conclusions: Primary preventive strategies are required to reduce the high frequency of modifiable risk factors predisposing to ICH in blacks.

Background and Purpose: Stroke subtypes and prognosis differ among older black patients compared with whites; however, few data are available regarding stroke among young black patients., Methods: To determine the risk factors for stroke, stroke subtype, and prognosis among young black patients, we retrospectively reviewed the medical records of all 15- to 44-year-old patients admitted with stroke to a university-affiliated public hospital from January 1990 through June 1994., Results: Of the 248 eligible patients admitted with stroke, 219 were blacks. Hypertension was more frequently associated with stroke in young black than in non-black patients (55% versus 24%, P = .003). Cocaine abuse was frequent among both black and non-black patients (27% versus 38%, P = NS). Hypertensive intracerebral hemorrhage (64%) was the most common subtype of intracerebral hemorrhage (n = 67), and lacunar infarction (21%) was the most common subtype of cerebral infarction (n = 112) in young black patients. Outcome in black patients with stroke at discharge was 69% independent, 8% dependent, and 23% dead., Conclusions: The high frequency of hypertension, hypertensive intracerebral hemorrhage, and lacunar infarction among young black patients with stroke suggests accelerated hypertensive arteriolar damage, possibly due to poor control of hypertension.

Background and Purpose: Black Americans with spontaneous intracerebral hemorrhage (SICH) may have unique clinical characteristics that affect outcome. The aim of this study was to determine the prognostic value of clinical characteristics and initial CT scan for outcome in black Americans with SICH., Methods: Clinical and demographic data were extracted from the charts of 182 consecutive black Americans admitted for SICH diagnosed by clinical criteria and initial CT scan. Hemorrhage volumes were calculated from admission CT scans by a computerized method. Univariate and multiple logistic regression analyses were performed to determine independent predictors of early deterioration (defined as a decrease from an initial Glasgow Coma Scale score > 12 by > or = 4 points within 24 hours from presentation) and mortality., Results: Both hemorrhage volume and ventricular extension were significant, independent predictors of early deterioration (odds ratio [OR], 6.78; 95% confidence interval [CI], 1.89 to 24.35 and OR, 4.67; 95% CI, 1.30 to 16.72, respectively) and mortality (OR, 6.66; 95% CI, 2.85 to 15.58 and OR, 4.23; 95% CI, 1.82 to 9.82, respectively). A Glasgow Coma Scale score < or = 12 also predicted mortality (OR, 3.23; 95% CI, 1.46 to 7.14). Initial mean arterial pressure was not an independent predictor of early deterioration or mortality., Conclusions: Hemorrhage volume and ventricular extension are the best predictors of early deterioration and mortality in black Americans with SICH.