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 |