POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

Study Overview
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Brief Summary
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The POST-conditioning during coronary angioplasty in Acute Myocardial Infarction (POST-AMI) trial will evaluate the usefulness of postconditioning in limiting infarct size and microvascular damage during the early and late phases after AMI.

Detailed Description
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POST-AMI is a single-center, prospective, randomized trial, with a planned inclusion of 78 patients with ST-elevation Acute Myocardial Infarction (AMI). Patients will be randomly assigned to postconditioning arm (primary angioplasty (PA) and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion) or non-postconditioning arm (PA and stenting without additional intervention). All patients will be treated medically according to current international guidelines, including glycoprotein IIb/IIIa inhibitors before PCI. The primary end point is to evaluate whether postconditioning, compared to PA without additional intervention, reduces infarct size estimated by magnetic resonance at 30±10 days after the AMI. Secondary end points are microvascular obstruction observed at magnetic resonance, ST-segment elevation resolution, persistent ST-segment elevation, angiographic myocardial blush grade <2 and non sustained/sustained ventricular tachycardia in the 48 hours following PA. Further secondary end points are enzymatic infarct size, left ventricular remodeling and left ventricular function at magnetic resonance performed at 6±1 months, and the reduction of major adverse cardiac events at 30 days and 6 months.

Official Title
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POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study (POST-AMI)

Conditions
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Myocardial Reperfusion Injury

Intervention / Treatment
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* Procedure: Postconditioning
* Procedure: Primary angioplasty and stenting without additional intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical evidence of myocardial infarction defined by the presence of ischemic chest pain lasting more than 30 minutes, with a time interval from the onset of symptoms less than 6 hours before hospital admission, associated with typical ST-segment elevation on the 12-lead ECG angiographic-detected culprit lesion with stenosis diameter >70% and TIMI flow grade <=1 Exclusion Criteria: previous acute myocardial infarction previous myocardial revascularization (angioplasty or coronary bypass) previous heart valve replacement previous heart transplant clinical instability precluding the suitability of the study cardiogenic shock or persistent hypotension (systolic blood pressure <100 mmHg) rescue angioplasty after thrombolytic therapy evidence of coronary collaterals (Rentrop grade>0) in the risk area advanced atrioventricular block significant bradycardia absence of sinus rhythm inability to lay flat (due to severe cardiac heart failure/respiratory insufficiency) history or clinical evidence of bronchospastic lung disease pregnancy known existence of a life-threatening disease with a life expectancy <6 months inability to give informed consent any contraindication to undergo cardiac-MRI, such as implanted metallic objects (cardiac pacemakers and/or implantable cardioverter defibrillator, implanted insulin pumps or any other type of electronic devices, cerebral clips, aneurysm clips) or any other contraindication to cardiac-MRI (such as claustrophobia)

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 |
| --- | --- |
| Active Comparator: Control<br>Primary angioplasty and stenting without additional intervention. | Procedure: Primary angioplasty and stenting without additional intervention<br>* Primary angioplasty and stenting without additional intervention.<br>|
| Experimental: Postconditioning<br>Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion. | Procedure: Postconditioning<br>* Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion<br>* Other names: Staccato Reperfusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size estimated by magnetic resonance |  | 30±10 days after myocardial infartion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular obstruction observed at magnetic resonance |  | 30±10 days after myocardial infarction | 
| ST-segment elevation resolution |  | First post-intervention ECG | 
| Persistent ST-segment elevation |  | At 24 and 48 hours post-intervention ECG | 
| Angiographic myocardial blush grade <2 |  | After primary angioplasty | 
| Non sustained/sustained ventricular tachycardia |  | Within 48 hours after miocardial infarction | 
| Enzymatic infarct size |  | Within 7 days after myocardial infarction | 
| Left ventricular remodeling and left ventricular function at MRI |  | At 6±1 months | 
| Incidence of Major Adverse Cardiac Events (MACE), defined as the combination of death, re-infarction, re-hospitalization for heart failure or repeat revascularization |  | At 30 days and at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myocardial infarction, Primary percutaneous coronary intervention, Postconditioning