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