Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
The purpose of this study is to determine whether brief periods of ischemia performed just at the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and infarct size in humans
Acute Myocardial Infarction
Procedure: Control group
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction|
- coronary reserve after intracoronary adenosine injection [ Time Frame: Immediately after the postconditioning procedure ] [ Designated as safety issue: No ]
- frequencies of low reflow and slow reflow situation [ Time Frame: after postconditioning ] [ Designated as safety issue: No ]
- regression of ST elevation [ Time Frame: 1h and 24h after postconditioning ] [ Designated as safety issue: No ]
- left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6) [ Time Frame: day 1 and 6 ] [ Designated as safety issue: No ]
- left ventricular systolic function by RMN [ Time Frame: day 8-12 ] [ Designated as safety issue: No ]
- myocardial blush [ Time Frame: after postconditioning ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||November 2011|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Placebo Comparator: - Control||
Procedure: Control group
Percutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group.
|Experimental: -postconditioning group||
patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion
Desobstruction of the culprit artery after acute myocardial infarction allows to reduce the consequences of prolonged ischemia. However, it is now clearly established that reperfusion induces by itself severe myocardial injuries. Postconditioning has been described as an adaptive response triggered by a brief ischemia applied after a prolonged coronary occlusion. Several teams have reported that ischemia/reperfusion cycles allow to reduce infarct size in experimental models.
Different pathophysiological processes have been proposed to explain the beneficial effect of postconditioning. It has been reported that postconditioning reduces the inflammatory response, and activates cardioprotective signaling pathways (Akt, eNOS, p70S6K). In addition, an improvement of the endothelial function has been reported.
This controlled trial aim to study the potential beneficial effect of postconditioning in patients with acute myocardial infarction. Forty six patients will be included in the study and the culprit artery will be reoccluded three times for 1 minutes after desobstruction in one of the both groups after randomization of the patients.
The evaluation will be focused on the comparison of the coronary reserve after intracoronary adenosine injection. In addition, additional parameters will be used to study the effect of postconditioning on post-ischemic endothelial dysfunction: frequencies of low reflow and slow reflow situation, myocardial blush and regression of ST elevation. The effect of postconditioning on the left ventricular systolic function will be studied by Doppler tissue imaging and RMN.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333320
|Henri Mondor University Hospital|
|Creteil, France, 94010|
|Principal Investigator:||Philippe Le Corvoisier, MD||Henri Mondor University Hospital|