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Background: The optimal diagnostic strategy for patients with chest pain and detectable to mildly elevated serum troponin is not known. The objective was to compare clinical outcomes among an early decision for a noninvasive versus an invasive-based care pathway., Methods: The CMR-IMPACT trial (Cardiac Magnetic Resonance Imaging Strategy for the Management of Patients with Acute Chest Pain and Detectable to Elevated Troponin) was conducted at 4 United States tertiary care hospitals from September 2013 to July 2018. A convenience sample of 312 participants with acute chest pain symptoms and a contemporary troponin between detectable and 1.0 ng/mL were randomized early in their care to 1 of 2 care pathways: invasive-based (n=156) or cardiac magnetic resonance (CMR)-based (n=156) with modification allowed as the patient condition evolved. The primary outcome was a composite including death, myocardial infarction, and cardiac-related hospital readmission or emergency visits., Results: Participants (N=312, mean age, 60.6 years, SD 11.3; 125 women [59.9%]), were followed over a median of 2.6 years (95% CI, 2.4-2.9). Early assigned testing was initiated in 102 out of 156 (65.3%) CMR-based and 110 out of 156 (70.5%) invasive-based participants. The primary outcome (CMR-based versus invasive-based) occurred in 59% versus 52% (hazard ratio, 1.17 [95% CI, 0.86-1.57]), acute coronary syndrome after discharge 23% versus 22% (hazard ratio, 1.07 [95% CI, 0.67-1.71]), and invasive angiography at any time 52% versus 74% (hazard ratio, 0.66 [95% CI, 0.49-0.87]). Among patients completing CMR imaging, 55 out of 95 (58%) were safely identified for discharge based on a negative CMR and did not have angiography or revascularization within 90 days. Therapeutic yield of angiography was higher in the CMR-based arm (52 interventions in 81 angiographies [64.2%] versus 46 interventions in 115 angiographies [40.0%] in the invasive-based arm [ P =0.001])., Conclusions: Initial management with CMR or invasive-based care pathways resulted in no detectable difference in clinical and safety event rates. The CMR-based pathway facilitated safe discharge, enriched the therapeutic yield of angiography, and reduced invasive angiography utilization over long-term follow-up., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT01931852., Competing Interests: Disclosures Dr Miller received research funding from Abbott, Research Triangle Institute (RTI) International (COVID-related), and Gifols Therapeutics (COVID-related). Dr Mahler receives funding/support from Roche Diagnostics, Abbott Laboratories, QuidelOrtho, Siemens, Grifols, Pathfast, Genetesis, Cytovale, National Heart, Lung, and Blood Institute (NHLBI; 1 R01 HL118263-01), and Health Resources and Services Administration (HRSA; 1H2ARH399760100). He is a consultant for Roche, Quidel, Abbott, Genetesis, Inflammatix, Radiometer, and Amgen and the Chief Medical Officer for Impathiq Inc. Dr Stopyra receives research funding from National Center for Advancing Translational Sciences (NCATS)/National Institutes of Health (NIH) (KL2TR001421), HRSA (H2ARH39976-01-00), NHLBI (U01HL123027), Roche Diagnostics, and Abbott Point of Care. He has provided paid consulting to Roche Diagnostics. Dr Hiestand receives research funding from Siemens. Dr Caterino receives research funding from National Institute on Aging (NIA)/NIH. Dr Snavely receives research funding from Abbott Laboratories, NHLBI (1 R01 HL118263-01), and HRSA (1 H2ARH399760100).

Objective: Use of point-of-care (POC) troponin (cTn) testing in the Emergency Department (ED) is well established. However, data examining POC cTn measurement in the prehospital setting, during ambulance transport, are limited. The objective of this study was to prospectively test the performance of POC cTn measurement by paramedics to detect myocardial infarction (MI) among patients transported to the ED for acute chest pain. Methods: A prospective cohort study of adults with non-traumatic chest pain was conducted in three Emergency Medical Services agencies (December 2016 to January 2018). Patients with ST-elevation MI on ECG were excluded. During ambulance transport paramedics initiated intravenous access, collected blood, and used a POC device (i-STAT; Abbott Laboratories) to measure cTn. Following ED arrival, participants received standard evaluations including clinical blood draws for cTn measurement in the hospital central lab (AccuTnI +3 assay; Beckman Coulter, or cTnI-Ultra assay; Siemens). Blood collected during ambulance transport was also analyzed for cTn in the central lab. Index visit MI was adjudicated by 3 experts using central lab cTn measures from the patient's clinical blood draws. Test characteristics (sensitivity, specificity, and predictive values) for detection of MI were calculated for POC and central lab cTn measurement of prehospital blood and compared with McNemar's test. Results: During the study period prehospital POC cTn results were obtained on 421 patients, of which 5.0% (21/421) had results >99th percentile upper reference limit. MI was adjudicated in 16.2% (68/421) during the index visit. The specificity and positive predictive value of the POC cTn measurement were 99.2% (95% CI 97.5-99.8%) and 85.7% (95% CI 63.7-97.0%) for MI. However, the sensitivity and NPV of prehospital POC cTn were 26.5% (95% CI 16.5-38.6%) and 87.5% (95% CI 83.9-90.6%). Compared to POC cTn, the central lab cTn measurement of prehospital blood resulted in a higher sensitivity of 67.9% (95% CI 53.7-80.1%, p  < 0.0001), but lower specificity of 92.4% (95% CI 88.4-95.4%, p  = 0.0001). Conclusions: Prehospital POC i-STAT cTn measurement in patients transported with acute chest pain was highly specific for MI but had low sensitivity. This suggests that prehospital i-STAT POC cTn could be useful to rule-in MI, but should not be used to exclude MI.

Clinical Trial Registration: clinicaltrials.gov (NCT02709135)., Competing Interests: Abbott Point of Care provided a research grant to support the work presented in this manuscript. Dr. Stopyra received research funding from Abbott Point of Care and Roche Diagnostics. Dr. Mahler receives additional research funding from Roche Diagnostics, Ortho Clinical Diagnostics, Siemens, Creavo Medical Technologies, the Donaghue Foundation, AHRQ, PCORI, and NHLBI (1 R01 HL118263-01, L30 HL120008). Dr. Mahler also serves as the chief medical officer of Impathiq, Inc. Dr. Miller also receives research funding / support from Siemens, Abbott Point of Care, and 1 R01 HL118263 These commercial affiliations do not alter our adherence to PLOS ONE policies on sharing data and materials.