Clinical trial NCT00333320: Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
Official title: Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Myocardial Infarction
Keywords: acute myocardial infarction
postconditioning
coronary reserve
ejection fraction
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2006-06-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: coronary reserve after intracoronary adenosine injection
timeFrame: Immediately after the postconditioning procedure
Secondary outcomes:
measure: frequencies of low reflow and slow reflow situation
timeFrame: after postconditioning
measure: regression of ST elevation
timeFrame: 1h and 24h after postconditioning
measure: left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)
timeFrame: day 1 and 6
measure: left ventricular systolic function by RMN
timeFrame: day 8-12
measure: myocardial blush
timeFrame: after postconditioning
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor University Hospital
Study officials:
affiliation: Henri Mondor University Hospital
name: Philippe Le Corvoisier, MD
role: PRINCIPAL_INVESTIGATOR
References: