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

September 18, 2008
September 19, 2008
December 5, 2013
September 2008
August 2010   (Final data collection date for primary outcome measure)
Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00755469 on Archive Site
The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
Post-conditioning to Reduce Infarct Size
Modification of Reperfusion by "Post-Conditioning" Reduces Infarct Size in Acute Myocardial Infarction

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.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Myocardial Infarction
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.
Experimental: 1
Intervention: Procedure: Post-conditioning

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Minneapolis Heart Institute Foundation
Minneapolis Heart Institute Foundation
Society for Cardiovascular Angiography and Interventions
Principal Investigator: Jay H Traverse, MD Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis Heart Institute Foundation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP