Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction

Study Overview
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Brief Summary
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RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.

Detailed Description
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In the management of STEMI, prompt reperfusion of the jeopardized myocardium is the most effective way to limit infarct size, which is a major determinant of morbidity and mortality. However, restoration of blood flow may paradoxically have deleterious consequences and lead to lethal myocardial ischemia-reperfusion injury. Local ischemic postconditioning (IPost) and remote ischemic preconditioning (RIPer) are promising methods to decrease ischemia-reperfusion injury. The hypothesis tested in this research proposal is that RIPer initiated at the time of the admission in the cathlab reduces infarct size in STEMI patients treated with PCI. Furthermore, the investigators will determine whether a combined approach RIPer + IPost can further reduce infarct size.

Official Title
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Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: Control
* Procedure: RIPer
* Procedure: RIPer + IPost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 ST-Segment elevation myocardial infarction <6h Written informed consent Exclusion Criteria: Previous Q-wave myocardial infarction or previous coronary artery bypass graft Cardiogenic shock Cardiac arrest resuscitated before angioplasty Infarct related artery : circumflex coronary artery, right coronary artery after segment 3, left main, diagonal and marginal branches, and all coronary artery with jeopardized myocardium estimated too small. TIMI 2 or 3 before angioplasty Collateral branches Rentrop >1 TIMI 0 or 1 flow grade after PCI Any contraindications to magnetic resonance imaging Allergy to gadolinium Patient refusal / patient not having provided written informed consent

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br> | Procedure: Control<br>* Deflated blood pressure cuff placed on upper arm for 30min<br>|
| Active Comparator: RIPer<br>Remote ischemic preconditioning | Procedure: RIPer<br>* Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total.<br>|
| Active Comparator: RIPer + IPost<br>Remote ischemic preconditioning and Local ischemic postconditioning | Procedure: RIPer + IPost<br>* Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total. Within the first minute of re-established coronary flow by primo-stenting, the same balloon is re-inflated for 1 min and then deflated for 1min. This procedure of balloon inflation/deflation is repeated 4 times in total.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size | Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular obstruction | Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up | 5 days | 
| Left ventricular remodeling | Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up | 3 months |