POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

University of Padova78 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myocardial Reperfusion Injury

Interventions

PostconditioningPROCEDURE

Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion

Primary angioplasty and stenting without additional interventionPROCEDURE

Primary angioplasty and stenting without additional intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy

Padua, Italy

Outcomes

Primary Outcomes

Infarct size estimated by magnetic resonance

Time frame: 30±10 days after myocardial infartion

Secondary Outcomes

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

Data from ClinicalTrials.gov

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