Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
postconditioning
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring acute myocardial infarction, postconditioning, coronary reserve, ejection fraction
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
Sites / Locations
- Henri Mondor University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
- Control
-postconditioning group
Arm Description
Outcomes
Primary Outcome Measures
coronary reserve after intracoronary adenosine injection
Secondary Outcome Measures
frequencies of low reflow and slow reflow situation
regression of ST elevation
left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)
left ventricular systolic function by RMN
myocardial blush
Full Information
NCT ID
NCT00333320
First Posted
June 2, 2006
Last Updated
October 22, 2012
Sponsor
French Cardiology Society
1. Study Identification
Unique Protocol Identification Number
NCT00333320
Brief Title
Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
Official Title
Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
acute myocardial infarction, postconditioning, coronary reserve, ejection fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
- Control
Arm Type
Placebo Comparator
Arm Title
-postconditioning group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
postconditioning
Intervention Description
patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention Description
Percutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group.
Primary Outcome Measure Information:
Title
coronary reserve after intracoronary adenosine injection
Time Frame
Immediately after the postconditioning procedure
Secondary Outcome Measure Information:
Title
frequencies of low reflow and slow reflow situation
Time Frame
after postconditioning
Title
regression of ST elevation
Time Frame
1h and 24h after postconditioning
Title
left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)
Time Frame
day 1 and 6
Title
left ventricular systolic function by RMN
Time Frame
day 8-12
Title
myocardial blush
Time Frame
after postconditioning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Le Corvoisier, MD
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor University Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
12. IPD Sharing Statement
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Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
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