NCT01004289

POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Reperfusion Injury

Interventions

Type	Name	Description
PROCEDURE	Postconditioning	Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion
PROCEDURE	Primary angioplasty and stenting without additional intervention	Primary angioplasty and stenting without additional intervention.

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2009-10-29
• Last updated: 2010-10-15

Locations

1 site across 1 country: Italy