Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)
|Myocardial Infarction||Procedure: Control Procedure: RIPer Procedure: RIPer + IPost||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)|
- 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
- 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
|Study Start Date:||July 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Deflated blood pressure cuff placed on upper arm for 30min
Active Comparator: RIPer
Remote ischemic preconditioning
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390142
|CHU Angers - Service de Cardiologie|
|Angers, France, 49933|
|Principal Investigator:||Fabrice Prunier, MD, PhD||University Hospital, Angers|