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Completed

NCT Number: NCT00333320

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

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Henri Mondor University Hospital

Créteil, 94010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postconditioning

Procedure

patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion

Control Group

Procedure

Percutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group.

Primary outcomes

  1. coronary reserve after intracoronary adenosine injection

    Time frame: Immediately after the postconditioning procedure

Secondary outcomes

  1. frequencies of low reflow and slow reflow situation

    Time frame: after postconditioning

  2. regression of ST elevation

    Time frame: 1h and 24h after postconditioning

  3. left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)

    Time frame: day 1 and 6

  4. left ventricular systolic function by RMN

    Time frame: day 8-12

  5. myocardial blush

    Time frame: after postconditioning

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Jun 5, 2006
Registry last updated
Oct 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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