POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study (POST-AMI)

October 14, 2010 updated by: University of Padova

POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study (POST-AMI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padua, Italy, 35128
        • Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Primary angioplasty and stenting without additional intervention.
Procedure: Primary angioplasty and stenting without additional intervention
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.
Procedure: Postconditioning
Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion
Other Names:
  • Staccato Reperfusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Microvascular obstruction observed at magnetic resonance
Time Frame: 30±10 days after myocardial infarction
30±10 days after myocardial infarction
ST-segment elevation resolution
Time Frame: First post-intervention ECG
First post-intervention ECG
Persistent ST-segment elevation
Time Frame: At 24 and 48 hours post-intervention ECG
At 24 and 48 hours post-intervention ECG
Angiographic myocardial blush grade <2
Time Frame: After primary angioplasty
After primary angioplasty
Non sustained/sustained ventricular tachycardia
Time Frame: Within 48 hours after miocardial infarction
Within 48 hours after miocardial infarction
Enzymatic infarct size
Time Frame: Within 7 days after myocardial infarction
Within 7 days after myocardial infarction
Left ventricular remodeling and left ventricular function at MRI
Time Frame: At 6±1 months
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
At 30 days and at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Investigators

  • Principal Investigator: Giuseppe Tarantini, MD, Ph.D., Department of Cardiac, Thoracic and Vascular Sciences, University of Padua

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (ESTIMATE)

October 29, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2010

Last Update Submitted That Met QC Criteria

October 14, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1328P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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