Post-conditioning to Reduce Infarct Size
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.
|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|
- 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 ]
- The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755469
|United States, Minnesota|
|Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|Principal Investigator:||Jay H Traverse, MD||Minneapolis Heart Institute at Abbott Northwestern Hospital|