Delayed Postconditioning

Study Overview
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Brief Summary
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The investigators previously reported that angioplasty postconditioning reduces infarct size (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital admission. Animal studies have suggested that the time window for applying brief episodes of ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow, i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window might be larger in humans, i.e. whether STEMI patients might be protected several minutes after undergoing spontaneous reperfusion before admission coronary angiography. Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade > 1 were eligible for that study. Angioplasty postconditioning was completed as already published and infarct size was assessed by measuring cardiac enzymes release.

Official Title
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Delayed Angioplasty Postconditioning in STEMI Patients

Conditions
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Myocardial Reperfusion Injury

Intervention / Treatment
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* Procedure: Postconditioning
* Procedure: Percutaneaous intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient > 18 years old Male or female Presenting first myocardial infarction, with the beginning of pains < 12 hours, Requiring a revascularisation by primary angioplasty or  rescue  (after failure of thrombolysis) on LAD or RCA (not Circumflex coronary artery). TIMI flow grade at admission of 2 or 3 LV angiography (RAO30°) before angioplasty. Exclusion Criteria: Cardiac arrest before the angioplasty Cardiogenic shock Occlusion of the artery circumflex responsible for the infarction Visible collaterals to the area at risk Magnetic resonance imaging: contra indication

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postconditionned<br>36 postconditionned patients | Procedure: Postconditioning<br>* Postconditioning consists of four cycles of one minute balloon inflation followed by one minute of balloon deflation, with the initial inflation being started within the first minute after reopening of the culprit coronary artery.<br>|
| Sham Comparator: Conventional intervention<br>36 control patients with conventional primary percutaneaous intervention (PCI) | Procedure: Percutaneaous intervention<br>* Conventional primary percutaneaous intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of the infarct | Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion | Day 5 post reperfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contractile functional recovery | Contractile functional recovery estimated by echocardiography at 6th month versus before discharge. | 6 months after reperfusion | 

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