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

University Hospital, Angers

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Procedure: Control; Procedure: RIPer; Procedure: RIPer + IPost

Study type: Interventional

Funder types: Other

Identifiers

NCT01390142

PHRC 2011-06

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Control

Experimental group

Treatment:

Procedure: Control

RIPer

Active Comparator group

Description:

Remote ischemic preconditioning

Treatment:

Procedure: RIPer

RIPer + IPost

Active Comparator group

Description:

Remote ischemic preconditioning and Local ischemic postconditioning

Treatment:

Procedure: RIPer + IPost