Post-conditioning to Reduce Infarct Size
|ClinicalTrials.gov Identifier: NCT00755469|
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : December 5, 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 or disease||Intervention/treatment|
|Myocardial Infarction||Procedure: Post-conditioning|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI [ Time Frame: 3 months ]
- The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|