POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

Overview

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.

Full Title of Study: “POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study (POST-AMI)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2010

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Control
    • Primary angioplasty and stenting without additional intervention.
  • Experimental: Postconditioning
    • Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion.

Clinical Trial Outcome Measures

Primary Measures

  • Infarct size estimated by magnetic resonance
    • Time Frame: 30±10 days after myocardial infartion

Secondary Measures

  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Padova
  • Provider of Information About this Clinical Study
    • Giuseppe Tarantini, Department of Cardiac, Thoracic and Vascular Sciences. University of Padua
  • Overall Official(s)
    • Giuseppe Tarantini, MD, Ph.D., Principal Investigator, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua

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