Clinical trial NCT01004289: POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study
Official title: POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study (POST-AMI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Reperfusion Injury
Keywords: Acute myocardial infarction
Primary percutaneous coronary intervention
Postconditioning
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Infarct size estimated by magnetic resonance
timeFrame: 30±10 days after myocardial infartion
Secondary outcomes:
measure: Microvascular obstruction observed at magnetic resonance
timeFrame: 30±10 days after myocardial infarction
measure: ST-segment elevation resolution
timeFrame: First post-intervention ECG
measure: Persistent ST-segment elevation
timeFrame: At 24 and 48 hours post-intervention ECG
measure: Angiographic myocardial blush grade <2
timeFrame: After primary angioplasty
measure: Non sustained/sustained ventricular tachycardia
timeFrame: Within 48 hours after miocardial infarction
measure: Enzymatic infarct size
timeFrame: Within 7 days after myocardial infarction
measure: Left ventricular remodeling and left ventricular function at MRI
timeFrame: At 6±1 months
measure: Incidence of Major Adverse Cardiac Events (MACE), defined as the combination of death, re-infarction, re-hospitalization for heart failure or repeat revascularization
timeFrame: At 30 days and at 6 months
Other outcomes:
Locations:
city: Padua
country: Italy
facility: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy
Study officials:
affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua
name: Giuseppe Tarantini, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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