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Design of clinical cardioprotection trials using CMR:Impact of myocardial salvage index and a narrow inclusion window on sample size
- Source :
- Engblom, H, Heiberg, E, Jensen, S E, Nordrehaug, J E, Dubois-Randé, J L, Halvorsen, S, Koul, S, Erlinge, D, Atar, D, Carlsson, M & Arheden, H 2015, ' Design of clinical cardioprotection trials using CMR : Impact of myocardial salvage index and a narrow inclusion window on sample size ', Journal of Cardiovascular Magnetic Resonance, vol. 17, no. Suppl. 1, P90 . https://doi.org/10.1186/1532-429X-17-S1-P90, Journal of Cardiovascular Magnetic Resonance
- Publication Year :
- 2015
-
Abstract
- Background Cardiac magnetic resonance imaging (CMR) can be used to determine both myocardial infarct (MI) size and myocardium at risk (MaR), enabling assessment of myocardial salvage index (MSI). MI size as assessed by hyperenhancement on late gadolinium enhancement (LGE) has been shown to decrease approximately 25% during the first week after infarction. The aim of this study was to determine to what extent assessment of MSI and a narrow inclusion window affect the number of patients needed to reach sufficient statistical power in a clinical CMR cardioprotection trial. Methods Control subjects (n=91) from the recent CHILL-MI 1 and MITOCARE 2 cardioprotection trials, examined by CMR 2-6 days after acute reperfusion therapy, were used to assess the difference in sample size required to reach sufficient statistical power when using MI size alone compared to MSI as outcome variable. In addition, 22 patients undergoing CMR at day 1 and 7 after acute reperfused infarction from a previous follow-up study 3 were included to assess to what extent sample size is affected by the decrease in hyperenhancement seen during the first week after infarction. The variability of MI size by LGE, MaR by contrast-enhanced SSFP and MSI was used to simulate 100.000 clinical trials for different assumed treatment effects to determine the number of patients needed to reach sufficient statistical power. Results
- Subjects :
- Medicine(all)
medicine.medical_specialty
Radiological and Ultrasound Technology
medicine.diagnostic_test
business.industry
Infarction
Steady-state free precession imaging
medicine.disease
Clinical trial
Reperfusion therapy
Sample size determination
Cardiac magnetic resonance imaging
Internal medicine
Poster Presentation
cardiovascular system
medicine
Cardiology
Radiology, Nuclear Medicine and imaging
cardiovascular diseases
Myocardial infarction
Cardiology and Cardiovascular Medicine
business
Angiology
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Engblom, H, Heiberg, E, Jensen, S E, Nordrehaug, J E, Dubois-Randé, J L, Halvorsen, S, Koul, S, Erlinge, D, Atar, D, Carlsson, M & Arheden, H 2015, ' Design of clinical cardioprotection trials using CMR : Impact of myocardial salvage index and a narrow inclusion window on sample size ', Journal of Cardiovascular Magnetic Resonance, vol. 17, no. Suppl. 1, P90 . https://doi.org/10.1186/1532-429X-17-S1-P90, Journal of Cardiovascular Magnetic Resonance
- Accession number :
- edsair.doi.dedup.....c2f6ccb721e33884b9351d2b2d8f1553