Clinical Outcomes of Angioplasty Postconditioning

Study Overview
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Brief Summary
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We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial infarction. It is currently unknown whether postconditioning actually decreases or simply delays myocardial cell death during reperfusion. In addition, the long term effects of postconditioning on recovery of myocardial contraction remains elusive. The objective of the present study is to determine whether infarct size reduction by angioplasty postconditioning is maintained at 6 months and whether functional recovery is improved at one year post-infarction.

Detailed Description
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Randomized, controlled, single-blinded trial comparing postconditioning to control (no intervention). Postconditioning consists of four episodes of one minute inflation followed by one minute deflation of the angioplasty balloon, starting within one minute of reflow after direct stenting of the occluded coronary artery.

Official Title
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Postconditioning and Functional Recovery After Acute Myocardial Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Procedure: Postconditioning
* Procedure: standard angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients, aged more than 18, with suspected first acute myocardial infarction, within 6 hours of the onset of chest pain, with a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty. Exclusion Criteria: Cardiac arrest or cardiogenic shock occlusion of the circumflex coronary artery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Post-conditioning during angioplasty | Procedure: Postconditioning<br>* Postconditioning during angioplasty<br>|
| Active Comparator: 2<br>standard angioplasty | Procedure: standard angioplasty<br>* standard angioplasty without postconditioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size as measured by cardiac enzymes and MRI at day 5 to 7 |  | during 72 hours after angioplasty, and at day 5 to 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month. |  | at 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemia, Reperfusion, Myocardial infarction, Postconditioning