Back to resultsPost-conditioning to Reduce Infarct Size
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Post-conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Reperfusion injury, Post-Conditioning, Infarct size
Eligibility Criteria
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
Sites / Locations
- Abbott Northwestern Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI
Secondary Outcome Measures
The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI
Full Information
NCT ID
NCT00755469
First Posted
September 18, 2008
Last Updated
December 3, 2013
Sponsor
Minneapolis Heart Institute Foundation
Collaborators
Society for Cardiovascular Angiography and Interventions
1. Study Identification
Unique Protocol Identification Number
NCT00755469
Brief Title
Post-conditioning to Reduce Infarct Size
Official Title
Modification of Reperfusion by "Post-Conditioning" Reduces Infarct Size in Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minneapolis Heart Institute Foundation
Collaborators
Society for Cardiovascular Angiography and Interventions
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Reperfusion injury, Post-Conditioning, Infarct size
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Post-conditioning
Intervention Description
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 Measure Information:
Title
Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay H Traverse, MD
Organizational Affiliation
Minneapolis Heart Institute at Abbott Northwestern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
16186417
Citation
Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.
Results Reference
background
PubMed Identifier
21136310
Citation
Garcia S, Henry TD, Wang YL, Chavez IJ, Pedersen WR, Lesser JR, Shroff GR, Moore L, Traverse JH. Long-term follow-up of patients undergoing postconditioning during ST-elevation myocardial infarction. J Cardiovasc Transl Res. 2011 Feb;4(1):92-8. doi: 10.1007/s12265-010-9252-0. Epub 2010 Dec 7.
Results Reference
result
Links:
URL
http://www.mplsheart.org
Description
The Minneapolis Heart Institute Foundation improves cardiovascular health through clinical research and education
Learn more about this trial
Post-conditioning to Reduce Infarct Size
We'll reach out to this number within 24 hrs