POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

Phase 2

Completed

• Conditions: Myocardial Reperfusion Injury
• Interventions: Procedure: Primary angioplasty and stenting without additional intervention; Procedure: Postconditioning

• Registration Number: NCT01004289
• Lead Sponsor: University of Padova

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-10-28
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Primary Completion: 2010-01
• Study Completion: 2010-04
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-14
• Last Update Posted: 2010-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Primary angioplasty and stenting without additional intervention	Primary angioplasty and stenting without additional intervention.
Postconditioning	Postconditioning	Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion.

Primary Outcome Measures

Name	Time	Method
Infarct size estimated by magnetic resonance	30±10 days after myocardial infartion

Secondary Outcome Measures

Name	Time	Method
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
Microvascular obstruction observed at magnetic resonance	30±10 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

Trial Locations

Locations (1)

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy; 🇮🇹 Padua, Italy