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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Procedure: Control; Procedure: RIPer; Procedure: RIPer + IPost

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU Angers - Service de Cardiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control	Procedure: Control; Deflated blood pressure cuff placed on upper arm for 30min
Active Comparator: RIPer; Remote ischemic preconditioning	Procedure: RIPer; 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.
Active Comparator: RIPer + IPost; Remote ischemic preconditioning and Local ischemic postconditioning	Procedure: RIPer + IPost; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Fédération Française de Cardiologie; Société Française de Cardiologie
• Investigators: Principal Investigator: Fabrice Prunier, MD, PhD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: July 6, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Estimate): October 18, 2013
• Last Update Submitted That Met QC Criteria: October 17, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: PHRC 2011-06