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

Primary Purpose

Myocardial Reperfusion Injury

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Postconditioning

Primary angioplasty and stenting without additional intervention

About this trial

This is an interventional treatment trial for Myocardial Reperfusion Injury focused on measuring Acute myocardial infarction, Primary percutaneous coronary intervention, Postconditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Postconditioning

Arm Description

Primary angioplasty and stenting without additional intervention.

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

Outcomes

Primary Outcome Measures

Infarct size estimated by magnetic resonance

Secondary Outcome Measures

Microvascular obstruction observed at magnetic resonance

ST-segment elevation resolution

Persistent ST-segment elevation

Angiographic myocardial blush grade <2

Non sustained/sustained ventricular tachycardia

Enzymatic infarct size

Left ventricular remodeling and left ventricular function at MRI

Incidence of Major Adverse Cardiac Events (MACE), defined as the combination of death, re-infarction, re-hospitalization for heart failure or repeat revascularization

Full Information

NCT ID

NCT01004289

First Posted

October 28, 2009

Last Updated

October 14, 2010

Sponsor

University of Padova

1. Study Identification

Unique Protocol Identification Number

NCT01004289

Brief Title

POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

Acronym

POST-AMI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Padova

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Reperfusion Injury

Keywords

Acute myocardial infarction, Primary percutaneous coronary intervention, Postconditioning

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Primary angioplasty and stenting without additional intervention.

Arm Title

Postconditioning

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Postconditioning

Other Intervention Name(s)

Staccato Reperfusion

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Primary angioplasty and stenting without additional intervention

Intervention Description

Primary angioplasty and stenting without additional intervention.

Primary Outcome Measure Information:

Title

Infarct size estimated by magnetic resonance

Time Frame

30±10 days after myocardial infartion

Secondary Outcome Measure Information:

Title

Microvascular obstruction observed at magnetic resonance

Time Frame

30±10 days after myocardial infarction

Title

ST-segment elevation resolution

Time Frame

First post-intervention ECG

Title

Persistent ST-segment elevation

Time Frame

At 24 and 48 hours post-intervention ECG

Title

Angiographic myocardial blush grade <2

Time Frame

After primary angioplasty

Title

Non sustained/sustained ventricular tachycardia

Time Frame

Within 48 hours after miocardial infarction

Title

Enzymatic infarct size

Time Frame

Within 7 days after myocardial infarction

Title

Left ventricular remodeling and left ventricular function at MRI

Time Frame

At 6±1 months

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Tarantini, MD, Ph.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Padua

ZIP/Postal Code

35128

Country

Italy

12. IPD Sharing Statement

Citations:

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POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

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