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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 2010
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.
- 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
- Infarct size estimated by magnetic resonance
- Time Frame: 30±10 days after myocardial infartion
- 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
- 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
- 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
- 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
- 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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