Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT00333320
First received: June 2, 2006
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Procedure: postconditioning
Procedure: Control group
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • coronary reserve after intracoronary adenosine injection [ Time Frame: Immediately after the postconditioning procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • frequencies of low reflow and slow reflow situation [ Time Frame: after postconditioning ] [ Designated as safety issue: No ]
  • regression of ST elevation [ Time Frame: 1h and 24h after postconditioning ] [ Designated as safety issue: No ]
  • left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6) [ Time Frame: day 1 and 6 ] [ Designated as safety issue: No ]
  • left ventricular systolic function by RMN [ Time Frame: day 8-12 ] [ Designated as safety issue: No ]
  • myocardial blush [ Time Frame: after postconditioning ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: September 2006
Study Completion Date: November 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333320

Locations
France
Henri Mondor University Hospital
Creteil, France, 94010
Sponsors and Collaborators
French Cardiology Society
Investigators
Principal Investigator: Philippe Le Corvoisier, MD Henri Mondor University Hospital
  More Information

No publications provided

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT00333320     History of Changes
Other Study ID Numbers: POSTCONDITIONING, SFC-2006-02
Study First Received: June 2, 2006
Last Updated: October 22, 2012
Health Authority: French : general directorate of health

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

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

ClinicalTrials.gov processed this record on August 20, 2014