Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Post-conditioning to Reduce Infarct Size

This study has been completed.
Sponsor:
Collaborator:
Society for Cardiovascular Angiography and Interventions
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT00755469
First received: September 18, 2008
Last updated: December 3, 2013
Last verified: December 2013

September 18, 2008
December 3, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00755469 on ClinicalTrials.gov Archive Site
The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00755469
opt002
No
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