PMID- 32854663 OWN - NLM STAT- MEDLINE DCOM- 20201123 LR - 20210110 IS - 1471-2377 (Electronic) IS - 1471-2377 (Linking) VI - 20 IP - 1 DP - 2020 Aug 27 TI - PRediction of acute coronary syndrome in acute ischemic StrokE (PRAISE) - protocol of a prospective, multicenter trial with central reading and predefined endpoints. PG - 318 LID - 10.1186/s12883-020-01903-0 [doi] LID - 318 AB - BACKGROUND: Current guidelines recommend measurement of troponin in acute ischemic stroke (AIS) patients. In AIS patients, troponin elevation is associated with increased mortality and worse outcome. However, uncertainty remains regarding the underlying pathophysiology of troponin elevation after stroke, particularly regarding diagnostic and therapeutic consequences. Troponin elevation may be caused by coronary artery disease (CAD) and more precisely acute coronary syndrome (ACS). Both have a high prevalence in stroke patients and contribute to poor outcome. Therefore, better diagnostic algorithms are needed to identify those AIS patients likely to have ACS or other manifestations of CAD. METHODS/DESIGN: The primary goal of the "PRediction of Acute coronary syndrome in acute Ischemic StrokE" (PRAISE) study is to develop a diagnostic algorithm for prediction of ACS in AIS patients. The primary hypothesis will test whether dynamic high-sensitivity troponin levels determined by repeat measurements (i.e., "rise or fall-pattern") indicate presence of ACS when compared to stable (chronic) troponin elevation. PRAISE is a prospective, multicenter, observational trial with central reading and predefined endpoints guided by a steering committee. Clinical symptoms, troponin levels as well as findings on electrocardiogram, echocardiogram, and coronary angiogram will be recorded and assessed by central academic core laboratories. Diagnosis of ACS will be made by an endpoint adjudication committee. Severe adverse events will be evaluated by a critical event committee. Safety will be judged by a data and safety monitoring board. Follow-up will be conducted at three and twelve months and will record new vascular events (i.e., stroke and myocardial infarction) as well as death, functional and cognitive status. According to sample size calculation, 251 patients have to be included. DISCUSSION: PRAISE will prospectively determine the frequency of ACS and characterize cardiac and coronary pathologies in a large, multicenter cohort of AIS patients with troponin elevation. The findings will elucidate the origin of troponin elevation, shed light on its impact on necessary diagnostic procedures and provide data on the safety and diagnostic yield of coronary angiography early after stroke. Thereby, PRAISE will help to refine algorithms and develop guidelines for the cardiac workup in AIS. TRIAL REGISTRATION: NCT03609385 registered 1st August 2018. FAU - Nolte, Christian H AU - Nolte CH AUID- ORCID: 0000-0001-5577-1775 AD - Klinik fur Neurologie mit Experimentelle Neurologie, Charite-Universitatsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany. Christian.nolte@charite.de. AD - Center for Stroke Research, Berlin, Germany. Christian.nolte@charite.de. AD - Berlin Institute of Health (BiH), Berlin, Germany. Christian.nolte@charite.de. AD - Deutsches Zentrum fur Herz-Kreislauf-Forschung e.V. (DZHK), 10785, Berlin, Germany. Christian.nolte@charite.de. AD - Deutsches Zentrum fur Neurodegenerative Erkrankungen (DZNE) - German Center for Neurodegenerative Diseases, 53127, Bonn, Germany. Christian.nolte@charite.de. FAU - von Rennenberg, Regina AU - von Rennenberg R AD - Klinik fur Neurologie mit Experimentelle Neurologie, Charite-Universitatsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany. AD - Center for Stroke Research, Berlin, Germany. AD - Deutsches Zentrum fur Neurodegenerative Erkrankungen (DZNE) - German Center for Neurodegenerative Diseases, 53127, Bonn, Germany. FAU - Litmeier, Simon AU - Litmeier S AD - Klinik fur Neurologie mit Experimentelle Neurologie, Charite-Universitatsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany. AD - Center for Stroke Research, Berlin, Germany. AD - Deutsches Zentrum fur Neurodegenerative Erkrankungen (DZNE) - German Center for Neurodegenerative Diseases, 53127, Bonn, Germany. FAU - Scheitz, Jan F AU - Scheitz JF AD - Klinik fur Neurologie mit Experimentelle Neurologie, Charite-Universitatsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany. AD - Center for Stroke Research, Berlin, Germany. AD - Berlin Institute of Health (BiH), Berlin, Germany. AD - Deutsches Zentrum fur Herz-Kreislauf-Forschung e.V. (DZHK), 10785, Berlin, Germany. FAU - Leistner, David M AU - Leistner DM AD - Berlin Institute of Health (BiH), Berlin, Germany. AD - Deutsches Zentrum fur Herz-Kreislauf-Forschung e.V. (DZHK), 10785, Berlin, Germany. AD - Medizinische Klinik fur Kardiologie, Campus Benjamin-Franklin, Charite-Universitatsmedizin, 12203, Berlin, Germany. FAU - Blankenberg, Stephan AU - Blankenberg S AD - Deutsches Zentrum fur Herz-Kreislauf-Forschung e.V. (DZHK), 10785, Berlin, Germany. AD - Klinik und Poliklinik fur Kardiologe, Universitares Herz- und Gefasszentrum, Universitatsklinikum, 20246, Hamburg, Germany. FAU - Dichgans, Martin AU - Dichgans M AD - Deutsches Zentrum fur Neurodegenerative Erkrankungen (DZNE) - German Center for Neurodegenerative Diseases, 53127, Bonn, Germany. AD - Institute for Stroke and Dementia Research (ISD), University Hospital, LMU Munich, 81377, Munich, Germany. AD - German Center for Neurodegenerative Diseases (DZNE, Munich) Partnersite, 81377, Munich, Germany. AD - Munich Cluster for Systems Neurology (SyNergy), 81377, Munich, Germany. FAU - Katus, Hugo AU - Katus H AD - Deutsches Zentrum fur Herz-Kreislauf-Forschung e.V. (DZHK), 10785, Berlin, Germany. AD - Klinik fur Kardiologie, Angiologie, Pneumologie, Universitatsklinikum Heidelberg, 69120, Heidelberg, Germany. FAU - Petzold, Gabor C AU - Petzold GC AD - Deutsches Zentrum fur Neurodegenerative Erkrankungen (DZNE) - German Center for Neurodegenerative Diseases, 53127, Bonn, Germany. AD - Sektion fur Vaskulare Neurologie, Klinik und Poliklinik fur Neurologie, Universitatsklinikum Bonn, 53105, Bonn, Germany. FAU - Pieske, Burkert AU - Pieske B AD - Deutsches Zentrum fur Herz-Kreislauf-Forschung e.V. (DZHK), 10785, Berlin, Germany. AD - Medizinische Klinik mit Schwerpunkt Kardiologie, Campus Virchow-Klinikum, Charite-Universitatsmedizin, 13353, Berlin, Germany. FAU - Regitz-Zagrosek, Vera AU - Regitz-Zagrosek V AD - Deutsches Zentrum fur Herz-Kreislauf-Forschung e.V. (DZHK), 10785, Berlin, Germany. AD - Institut fur Geschlechterforschung in der Medizin (Gender in Medicine, GiM), Charite-Universitatsmedizin, 10115, Berlin, Germany. FAU - Wegscheider, Karl AU - Wegscheider K AD - Institut fur Medizinische Biometrie und Epidemiologie, Universitatsklinikum Hamburg-Eppendorf, 20251, Hamburg, Germany. FAU - Zeiher, Andreas M AU - Zeiher AM AD - Deutsches Zentrum fur Herz-Kreislauf-Forschung e.V. (DZHK), 10785, Berlin, Germany. AD - Klinik fur Kardiologie, Angiologie, Nephrologie, Uniklinik Frankfurt, 60590, Frankfurt am Main, Germany. FAU - Landmesser, Ulf AU - Landmesser U AD - Berlin Institute of Health (BiH), Berlin, Germany. AD - Deutsches Zentrum fur Herz-Kreislauf-Forschung e.V. (DZHK), 10785, Berlin, Germany. AD - Medizinische Klinik fur Kardiologie, Campus Benjamin-Franklin, Charite-Universitatsmedizin, 12203, Berlin, Germany. FAU - Endres, Matthias AU - Endres M AD - Klinik fur Neurologie mit Experimentelle Neurologie, Charite-Universitatsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany. AD - Center for Stroke Research, Berlin, Germany. AD - Berlin Institute of Health (BiH), Berlin, Germany. AD - Deutsches Zentrum fur Herz-Kreislauf-Forschung e.V. (DZHK), 10785, Berlin, Germany. AD - Deutsches Zentrum fur Neurodegenerative Erkrankungen (DZNE) - German Center for Neurodegenerative Diseases, 53127, Bonn, Germany. AD - Medizinische Klinik fur Kardiologie, Campus Benjamin-Franklin, Charite-Universitatsmedizin, 12203, Berlin, Germany. AD - Excellence Cluster NeuroCure, 10117, Berlin, Germany. LA - eng SI - ClinicalTrials.gov/NCT03609385 GR - DZHK 19/Deutsches Zentrum fur Herz-Kreislaufforschung/ GR - DZNE B001/Deutsches Zentrum fur Neurodegenerative Erkrankungen/ PT - Clinical Trial Protocol PT - Journal Article PT - Multicenter Study DEP - 20200827 PL - England TA - BMC Neurol JT - BMC neurology JID - 100968555 RN - 0 (Biomarkers) RN - 0 (Troponin) SB - IM MH - Acute Coronary Syndrome/*diagnosis MH - Biomarkers/analysis MH - Brain Ischemia/*complications MH - Coronary Angiography/methods MH - Coronary Artery Disease/diagnosis MH - Electrocardiography/methods MH - Humans MH - Myocardial Infarction/diagnosis MH - Prospective Studies MH - Stroke/*complications MH - Troponin/*analysis PMC - PMC7450553 OTO - NOTNLM OT - Acute coronary syndrome OT - Acute ischemic stroke OT - Chronic coronary disease OT - Heart-and-brain interaction OT - Stroke-heart-syndrome OT - Troponin elevation COIS- ME reports grants from Bayer and fees paid to the Charite from Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Amgen, GSK, Sanofi, Covidien, Novartis, Pfizer, all outside the submitted work. CHN reports lecture fees and/or consultancies from Boehringer Ingelheim, BMS, Daiichi Sankyo, Sanofi, Pfizer, Abbott and Gore & Ass.. EDAT- 2020/08/29 06:00 MHDA- 2020/11/24 06:00 PMCR- 2020/08/27 CRDT- 2020/08/29 06:00 PHST- 2020/03/27 00:00 [received] PHST- 2020/08/23 00:00 [accepted] PHST- 2020/08/29 06:00 [entrez] PHST- 2020/08/29 06:00 [pubmed] PHST- 2020/11/24 06:00 [medline] PHST- 2020/08/27 00:00 [pmc-release] AID - 10.1186/s12883-020-01903-0 [pii] AID - 1903 [pii] AID - 10.1186/s12883-020-01903-0 [doi] PST - epublish SO - BMC Neurol. 2020 Aug 27;20(1):318. doi: 10.1186/s12883-020-01903-0.