POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

Phase 2

Completed

• Conditions: Myocardial Reperfusion Injury

• 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

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