Effect of Remote Ischaemic Conditioning on Clinical Outcomes in ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention (CONDI2/ERIC-PPCI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University College, London
- Enrollment
- 5,413
- Locations
- 35
- Primary Endpoint
- Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Onset of STEMI symptoms within 12 hours, lasting for more than 30 minutes
- •Patients older than 18 years
- •Suspected STEMI (ST-elevation at the J-point in two contiguous leads with the cutoff points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads)
Exclusion Criteria
- •Previous coronary artery bypass graft surgery
- •Myocardial infarction within the previous 30 days
- •Treatment with thrombolysis within the previous 30 days
- •Left bundle branch block
- •Patients treated with therapeutic hypothermia
- •Conditions precluding use of RIC (paresis of upper limb, use of an a-v shunt)
- •Life expectancy of less than 1 year due to non-cardiac pathology
Arms & Interventions
Remote ischemic conditioning
AutoRIC device will be placed on the upper arm and an active RIC protocol will be delivered (4x5 min cycles of inflation to 200mmHg and deflation) prior to PPCI.
Intervention: Remote ischemic conditioning (Device)
Sham control
Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI.
Intervention: Control (Device)
Outcomes
Primary Outcomes
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.
Time Frame: One year
Secondary Outcomes
- Rates of cardiac death and HHF at 30 days.(30 days)
- Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.(12 months)
- TIMI flow post-PPCI.(1 week)
- Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).(One year)
- Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers(1 week)
- CMR substudy: Cardiac MRI in first week and at 6 months(6 months)