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

Overview

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 Title of Study: “Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

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.

Interventions

  • Procedure: Control
    • Deflated blood pressure cuff placed on upper arm for 30min
  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Control
  • Active Comparator: RIPer
    • Remote ischemic preconditioning
  • Active Comparator: RIPer + IPost
    • Remote ischemic preconditioning and Local ischemic postconditioning

Clinical Trial Outcome Measures

Primary Measures

  • Infarct size
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Angers
  • Collaborator
    • Fédération Française de Cardiologie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fabrice Prunier, MD, PhD, Principal Investigator, University Hospital, Angers

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