Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT00333320|
Recruitment Status : Completed
First Posted : June 5, 2006
Last Update Posted : October 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Procedure: postconditioning Procedure: Control group||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction|
|Study Start Date :||September 2006|
|Primary Completion Date :||July 2010|
|Study Completion Date :||November 2011|
|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
- coronary reserve after intracoronary adenosine injection [ Time Frame: Immediately after the postconditioning procedure ]
- frequencies of low reflow and slow reflow situation [ Time Frame: after postconditioning ]
- regression of ST elevation [ Time Frame: 1h and 24h after postconditioning ]
- left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6) [ Time Frame: day 1 and 6 ]
- left ventricular systolic function by RMN [ Time Frame: day 8-12 ]
- myocardial blush [ Time Frame: after postconditioning ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333320
|Henri Mondor University Hospital|
|Creteil, France, 94010|
|Principal Investigator:||Philippe Le Corvoisier, MD||Henri Mondor University Hospital|