NCT01390142

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-07-08
• Last updated: 2013-10-18

Locations

1 site across 1 country: France