Post-conditioning to Reduce Infarct Size

This study has been completed.
Society for Cardiovascular Angiography and Interventions
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation Identifier:
First received: September 18, 2008
Last updated: December 3, 2013
Last verified: December 2013

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 Intervention
Myocardial Infarction
Procedure: Post-conditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Modification of Reperfusion by "Post-Conditioning" Reduces Infarct Size in Acute Myocardial Infarction

Resource links provided by NLM:

Further study details as provided by Minneapolis Heart Institute Foundation:

Primary Outcome Measures:
  • Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: September 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00755469

United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Society for Cardiovascular Angiography and Interventions
Principal Investigator: Jay H Traverse, MD Minneapolis Heart Institute at Abbott Northwestern Hospital
  More Information

Additional Information:
Responsible Party: Minneapolis Heart Institute Foundation Identifier: NCT00755469     History of Changes
Other Study ID Numbers: opt002 
Study First Received: September 18, 2008
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Minneapolis Heart Institute Foundation:
Reperfusion injury
Infarct size

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases processed this record on May 22, 2016