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

Phase 3

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: RIPer; Procedure: RIPer + IPost; Procedure: Control

• Registration Number: NCT01390142
• Lead Sponsor: University Hospital, Angers

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-17
• Last Update Posted: 2013-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPer	RIPer	Remote ischemic preconditioning
RIPer + IPost	RIPer + IPost	Remote ischemic preconditioning and Local ischemic postconditioning
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Infarct size	3 months	Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up

Secondary Outcome Measures

Name	Time	Method
Microvascular obstruction	5 days	Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up
Left ventricular remodeling	3 months	Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up

Trial Locations

Locations (1)

CHU Angers - Service de Cardiologie; 🇫🇷 Angers, France