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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
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Procedure: postconditioning Procedure: Control group Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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

Primary Outcome Measures :
  1. coronary reserve after intracoronary adenosine injection [ Time Frame: Immediately after the postconditioning procedure ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
French Cardiology Society
Principal Investigator: Philippe Le Corvoisier, MD Henri Mondor University Hospital

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT00333320     History of Changes
First Posted: June 5, 2006    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

Keywords provided by French Cardiology Society:
acute myocardial infarction
coronary reserve
ejection fraction

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases