Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction

Phase 1

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Procedure: postconditioning; Procedure: Control group

• Registration Number: NCT00333320
• Lead Sponsor: French Cardiology Society

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-05
• Study Start: 2006-09
• Primary Completion: 2010-07
• Study Completion: 2011-11
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-22
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Acute myocardial infarction (<6 hours)
• Occlusion of a major coronary vessel

Exclusion Criteria

• History of previous myocardial infarction
• History of Coronary Artery Bypass Grafting
• Need for Coronary Artery Bypass Grafting
• Stenosis not eligible for angioplasty
• Limited ischemic area
• Cardiogenic shock
• Interventricular septum rupture
• Mitral regurgitation>2
• Ventricular tachycardia
• Atrioventricular block class II and III

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
-postconditioning group	postconditioning	-
- Control	Control group	-

Primary Outcome Measures

Name	Time	Method
coronary reserve after intracoronary adenosine injection	Immediately after the postconditioning procedure

Secondary Outcome Measures

Name	Time	Method
frequencies of low reflow and slow reflow situation	after postconditioning
regression of ST elevation	1h and 24h after postconditioning
left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)	day 1 and 6
left ventricular systolic function by RMN	day 8-12
myocardial blush	after postconditioning

Trial Locations

Locations (1)

Henri Mondor University Hospital; 🇫🇷 Creteil, France