Post-conditioning to Reduce Infarct Size

Sponsor

Minneapolis Heart Institute Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00755469

Collaborator

Society for Cardiovascular Angiography and Interventions (Other)

Enrollment

Location

Arm

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

When angioplasty (PTCA) and stenting of the blood vessels of the heart is the treatment for a Heart Attack, there is damage to the heart muscle that is caused by the sudden opening of the blood vessels. This is called "reperfusion injury". The cell death is due to inflammation and the generation of free radicals.

The primary objective of this study is to determine if post-conditioning(four brief (30 second) PTCA balloon inflations) reduces damage to the heart muscle. This will be measured by heart enzyme tests-CK measurements- and by cardiac MRI.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Procedure: Post-conditioning	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Modification of Reperfusion by "Post-Conditioning" Reduces Infarct Size in Acute Myocardial Infarction

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Procedure: Post-conditioning The post-conditioning protocol consists of performing 4, 30-second PTCA balloon occlusions followed by 30 seconds of reperfusion for a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery and flow is restored. Following this protocol the vessel will be stented as part of usual practice for treatment of acute MI.

Arm

Intervention/Treatment

Experimental: 1

Procedure: Post-conditioning

The post-conditioning protocol consists of performing 4, 30-second PTCA balloon occlusions followed by 30 seconds of reperfusion for a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery and flow is restored. Following this protocol the vessel will be stented as part of usual practice for treatment of acute MI.

Outcome Measures

Primary Outcome Measures

Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI [3 months]

Secondary Outcome Measures

The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 < 80
Able to give informed consent
100% occlusion of a major epicardial vessel with TIMI 0 Flow

Exclusion Criteria:

Significant collateral blood flow to the distal vasculature of the occluded vessel.
Previous CABG
Previous q-wave myocardial infarction in the same territory