Prognostic impact of COronary Angiography in patients with acute ischemic Stroke and Troponin elevatio

Not Applicable

• Conditions: I63; Cerebral infarction

• Registration Number: DRKS00033905
• Lead Sponsor: niversität Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

[1] Written informed consent obtained from the patient or their guardian or written indication by the attending physician.
[2] Age 40-90 years.
[3] Acute ischemic stroke with clinical and morphologic signs in the past 72 hours.
[4] Increase in absolute troponin values depending on the troponin tests available in the respective study center according to the current ACS guidelines. This means either highly sensitive troponin assays (hs-cTN) or conventional cTN assays with an increase and/or decrease above the 99th percentile of a healthy reference population (4th universal myocardial infarction definition).
[5] One of these criteria must be met:
- At least 3 cardiovascular risk factors from
o Obesity (BMI >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 CHD
- Increase in high-sensitivity troponin to = 5 times the upper norm
- Previously known/intervened obstructive or non-obstructive coronary heart disease with at least 50% stenosis in at least one coronary vessel

Exclusion Criteria

[1] Invasive exclusion of coronary heart disease (CHD) in the previous 12 months.
[2] Acute ST-segment myocardial infarction (STEMI), according to European ACS guideline (Byrne 2023 EHJ), New ST elevation at the J-point in at least two contiguous leads: - =2.5 mm in men =2mm in men =40 years, or =1.5 mm in women regardless of age in leads V2-V3 and/or =1 mm in the other leads (in the absence of left ventricular [LV] hypertrophy or left bundle branch block [LBBB]) documented in all uptake 12-lead ECGs plus at the time of study inclusion.
[3] History of grade III valvular heart disease.
[4] Current endocarditis.
[5] GOLD E stage COPD and/or COPD requiring long-term oxygenation.
[6] Pregnancy or breastfeeding.
[7] Absolute contraindications for 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 < 50,000/µl at index hospitalization.
[9] Severe acute infection, defined as C-reactive protein >100 g/dl and/or leukocytosis >15,000/µl in combination with a clinical focus of infection.
[10] Sepsis and septic shock according to the Sepsis 3 criteria.
[11] Malignancy or comorbidity with a life expectancy of =12 months.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE, defined as the composite of death, myocardial infarction (type I and II) and coronary revascularization (i.e. PCI or CABG).

Secondary Outcome Measures

Name	Time	Method
ajor adverse cardiac and cerebrovascular events (MACCE, defined as the composite of death, myocardial infarction (type I and II), any type of coronary revascularization (i.e. PCI or CABG) or stroke).