PRediction of acute coronary syndrome in acute ischemic StrokE (PRAISE) - protocol of a prospective, multicenter trial with central reading and predefined endpoints.
Acute coronary syndrome
Acute ischemic stroke
Chronic coronary disease
Heart-and-brain interaction
Stroke-heart-syndrome
Troponin elevation
Journal
BMC neurology
ISSN: 1471-2377
Titre abrégé: BMC Neurol
Pays: England
ID NLM: 100968555
Informations de publication
Date de publication:
27 Aug 2020
27 Aug 2020
Historique:
received:
27
03
2020
accepted:
23
08
2020
entrez:
29
8
2020
pubmed:
29
8
2020
medline:
24
11
2020
Statut:
epublish
Résumé
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. 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. 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. NCT03609385 registered 1st August 2018.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
NCT03609385 registered 1st August 2018.
Identifiants
pubmed: 32854663
doi: 10.1186/s12883-020-01903-0
pii: 10.1186/s12883-020-01903-0
pmc: PMC7450553
doi:
Substances chimiques
Biomarkers
0
Troponin
0
Banques de données
ClinicalTrials.gov
['NCT03609385']
Types de publication
Clinical Trial Protocol
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
318Subventions
Organisme : Deutsches Zentrum für Herz-Kreislaufforschung
ID : DZHK 19
Organisme : Deutsches Zentrum für Neurodegenerative Erkrankungen
ID : DZNE B001
Références
Stroke. 2017 Nov;48(11):2952-2957
pubmed: 29042492
BMJ. 2018 Dec 18;363:k5130
pubmed: 30563885
J Am Coll Cardiol. 2016 May 10;67(18):2135-2144
pubmed: 27151345
Stroke. 2019 Dec;50(12):3335-3336
pubmed: 31637973
Circulation. 2016 Jan 26;133(4):e38-360
pubmed: 26673558
Fortschr Neurol Psychiatr. 1999 Feb;67(2):81-93
pubmed: 10093781
JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035
pubmed: 27712739
Am J Cardiol. 2002 Aug 1;90(3):248-53
pubmed: 12127612
Cerebrovasc Dis. 2009;28(3):220-6
pubmed: 19571535
Stroke. 2018 Mar;49(3):e46-e110
pubmed: 29367334
PLoS Med. 2009 Apr 21;6(4):e1000057
pubmed: 19381280
Z Gerontol Geriatr. 2012 Apr;45(3):218-23
pubmed: 21769513
J Am Heart Assoc. 2018 Jan 18;7(2):
pubmed: 29348322
Ann Neurol. 2017 Apr;81(4):502-511
pubmed: 28253544
Cochrane Database Syst Rev. 2015 Mar 12;(3):CD000024
pubmed: 25764172
J Health Soc Behav. 1983 Dec;24(4):385-96
pubmed: 6668417
Eur Heart J. 2016 Jan 14;37(3):267-315
pubmed: 26320110
Circulation. 2016 Mar 29;133(13):1264-71
pubmed: 26933082
Stroke. 2011 Jan;42(1):22-9
pubmed: 21088246
Lancet. 2005 Jul 2-8;366(9479):29-36
pubmed: 15993230
Atherosclerosis. 2019 Aug;287:181-183
pubmed: 31104809
Lancet. 2000 May 13;355(9216):1670-4
pubmed: 10905241
N Engl J Med. 2007 Feb 22;356(8):830-40
pubmed: 17314342
Circulation. 2016 May 31;133(22):2141-8
pubmed: 27185168
Lancet Neurol. 2018 Dec;17(12):1109-1120
pubmed: 30509695
Stroke. 2015 Apr;46(4):1132-40
pubmed: 25737317
Int J Cardiol. 2012 May 31;157(2):239-42
pubmed: 22326514
Stroke. 2007 Aug;38(8):2295-302
pubmed: 17569877
Eur J Neurol. 2014 Nov;21(11):1387-93
pubmed: 25040216