Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effect of Remote Ischaemic Conditioning on Clinical Outcomes in ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention (CONDI2/ERIC-PPCI)

Conditions
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STEMI, Myocardial Reperfusion Injury

Intervention / Treatment
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* Device: Remote ischemic conditioning
* Device: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote ischemic conditioning<br>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. | Device: Remote ischemic conditioning<br>* 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.<br>|
| Sham Comparator: Sham control<br>Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI. | Device: Control<br>* An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardioprotection, STEMI, PPCI, Myocardial reperfusion injury, Myocardial infarct size, ST-elevation myocardial infarction, Remote Ischaemic Conditioning, Cardiovascular mortality