PRediction of acute coronary syndrome in acute ischemic StrokE (PRAISE) – protocol of a prospective, multicenter trial with central reading and predefined endpoints

Table 1 Frequency and scope of study visits

	Screening visit / Inclusion	Study procedures	Follow-up 1	Follow-up 2
	< 72 h after admission	< day 7 d	3 months	12 months
Inclusion/Exclusion criteria	X
Informed consent	X
General examination
Medical history/comorbidities	X
Physical examination	X
Current Medication	X	X
Neurological exam./NIHSS	X	X
Degree of disability (mRS)	X	X	X	X
Psychological stress assessment (PSS)		X
GRACE score	X
Montreal Cognitive Assessment (MoCA)	X
Severe Adverse Events of Special Interest (SAESI)	X	X	X	X
Laboratory evaluation
Serial troponin	X
Local blood chemistry	X
Diagnostic procedures	(assessment in central, blinded core laboratories)
Brain imaging (CT/MRI)	X
12-lead surface ECG	X	X
Echocardiography		X
Coronary angiography		X
Endpoints
Primary Acute coronary syndrome (ACS)	Adjudication by Endpoint Adjudication Committee (EAC) based on clinical data and the reports of blinded core-labs
Secondary New vascular events and Safety
Stroke, TIA, MI, death, bleeding		X	X	X
		SAESI Independent assessment by critical events committee (CEC)
Cognitive Outcome
Montreal Cognitive Assessment (MoCA)		X
Telephone Interview on Cognitive Status			X	X

NIHSS National Institutes of Health Stroke Scale, mRS Modified Rankin Scale, ECG Electrocardiography, CT Cerebral computed tomography, MRI Cerebral magnetic resonance imaging, MI Myocardial infarction, TIA Transient ischemic attack, SAESI Severe adverse event of special interest

ISSN: 1471-2377