The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure at 12 months in patients presenting with a ST-elevation myocardial infarction and treated by percutaneous coronary intervention.
The CONDI2/ERIC-PPCI trial is a randomised controlled clinical trial investigating whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in 5400 patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5,413
An automated autoRIC™ cuff will be placed on the upper arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle which will be undertaken 4 times in total.
An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.
Time frame: One year
Rates of cardiac death and HHF at 30 days.
Time frame: 30 days
Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.
Time frame: 12 months
TIMI flow post-PPCI.
Time frame: 1 week
Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).
Time frame: One year
Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers
Time frame: 1 week
CMR substudy: Cardiac MRI in first week and at 6 months
Time frame: 6 months
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