Clinical Trial: POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study (POST-AMI)
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 Summary: 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.
Sponsor: University of Padua
Current Primary Outcome: Infarct size estimated by magnetic resonance [ Time Frame: 30±10 days after myocardial infartion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Microvascular obstruction observed at magnetic resonance [ Time Frame: 30±10 days after myocardial infarction ]
- ST-segment elevation resolution [ Time Frame: First post-intervention ECG ]
- Persistent ST-segment elevation [ Time Frame: At 24 and 48 hours post-intervention ECG ]
- Angiographic myocardial blush grade <2 [ Time Frame: After primary angioplasty ]
- Non sustained/sustained ventricular tachycardia [ Time Frame: Within 48 hours after miocardial infarction ]
- Enzymatic infarct size [ Time Frame: Within 7 days after myocardial infarction ]
- Left ventricular remodeling and left ventricular function at MRI [ Time Frame: 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 [ Time Frame: At 30 days and at 6 months ]
Original Secondary Outcome: Same as current
Information By: University of Padua
Dates:
Date Received: October 28, 2009
Date Started: April 2007
Date Completion:
Last Updated: October 14, 2010
Last Verified: October 2010