I63
Conditions
Interventions
Group 1: Invasive coronary angiography (CA) with potential need for revascularization (i.e. either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)). Invasive CA with po
Sponsors
Universität Heidelberg
Eligibility
Sex/Gender
All
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: [1] Written informed consent obtained from the patient or their guardian or written indication by the attending physician. [2] Age 40-85 years. [3] Admission due to acute ischemic stroke within 72 hours prior to admission to the stroke unit. [4] Increase in absolute troponin values above the 99th percentile of a healthy reference population (4th universal myocardial infarction definition), depending on the troponin tests available at the respective study center (high-sensitivity cardiac troponin assays (hs-cTn) or conventional cTn assays) according to the 2023 ESC ACS guidelines (acute coronary syndrome) (Byrne et al., 2023). [5] One of these criteria must be met: - At least 3 cardiovascular risk factors from o Obesity (BMI (Body Mass Index) >30kg/m2) o Arterial hypertension (treated with medication) o Diabetes mellitus (treated with medication or diet) o Dyslipoproteinemia (LDL >150mg/dl or drug therapy) o Harmful use of tobacco (active smoking) o familial disposition for coronary artery disease (CAD) - Increase in high-sensitivity troponin to = 5 times the upper norm - Previously known/intervened coronary heart disease with at least 50% stenosis in at least one coronary vessel.
Exclusion criteria
Exclusion criteria: [1] Invasive exclusion of CAD in the previous 12 months. [2] Acute ST-segment elevation myocardial infarction (STEMI) according to 2023 ESC ACS guideline (Byrne et al., 2023) at the time of study inclusion. [3] History of untreated grade III valvular heart disease. [4] Current endocarditis. [5] COPD (Chronic Obstructive Pulmonary Disease) stage GOLD E and/or COPD requiring long-term oxygenation. [6] Pregnancy or breastfeeding. [7] Absolute contraindications for early CA (e.g. hemorrhagic infarction, defined as parenchymal hematoma (PH) 1 and PH 2 according to Fiorelli (1999), planned urgent surgery with absolute contraindication. [8] Persistent platelet count 100 g/dl and/or leukocytosis >15,000/µl in combination with a clinical focus of infection. [10] Severe sepsis or septic shock. [11] Malignancy or comorbidity with a life expectancy of =12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE rate (Death, acute myocardial infarction, unplanned coronary revascularization (i.e. PCI (Percutaneous Coronary Intervention) or CABG (Coronary Artery Bypass Graft)) within 12 months of randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Major adverse cardiac and cerebrovascular events (MACCE, defined here as the totality of death, acute myocardial infarction, unplanned coronary revascularization (i.e. PCI (Percutaneous Coronary Intervention) or CABG (Coronary Artery Bypass Graft) or stroke). - Rehospitalization for acute cardiological or neurological reasons. - Rehospitalization due to heart failure. - After 12 months: Assessment of quality of life using the Short Form 36 Health Survey (SF-36) and the Modified Rankin Scale (mRS). | — |
Countries
Germany
Contacts
Public ContactIbrahim Akin
Universitätsmedizin Mannheim
Outcome results
None listed