Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction

October 22, 2012 updated by: French Cardiology Society
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Henri Mondor University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: postconditioning
patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
coronary reserve after intracoronary adenosine injection
Time Frame: Immediately after the postconditioning procedure
Immediately after the postconditioning procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Investigators

  • Principal Investigator: Philippe Le Corvoisier, MD, Henri Mondor University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 2, 2006

First Posted (Estimate)

June 5, 2006

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POSTCONDITIONING
  • SFC-2006-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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