Post-conditioning to Reduce Infarct Size

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00755469
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : December 5, 2013
Society for Cardiovascular Angiography and Interventions
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation

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
Myocardial Infarction Procedure: Post-conditioning

Study Type : Interventional  (Clinical Trial)
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 : September 2008
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Publications of Results:
Other Publications:
Traverse JH, Wang YL, Chavez, IJ, Lesser JR, Pedersen WR, Mirheydar H, Henry TD. Post Conditioning reduces infarct size and improves LV function during acute myocardial infarction. Circulation 2006;114:II-344.

Responsible Party: Minneapolis Heart Institute Foundation Identifier: NCT00755469     History of Changes
Other Study ID Numbers: opt002
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: December 2013

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

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases