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

Myocardial Infarction Clinical Trial

— RIRE-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390142
• Other study ID #: PHRC 2011-06
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2011
• Last updated: October 17, 2013
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: October 2013
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
France	CHU Angers - Service de Cardiologie	Angers

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	Fédération Française de Cardiologie, Société Française de Cardiologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Microvascular obstruction	Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up	5 days	No
Secondary	Left ventricular remodeling	Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up	3 months	No