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
  Purpose

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 Intervention
Myocardial Infarction
Procedure: Post-conditioning

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Minneapolis Heart Institute Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: September 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755469

Locations
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Society for Cardiovascular Angiography and Interventions
Investigators
Principal Investigator: Jay H Traverse, MD Minneapolis Heart Institute at Abbott Northwestern Hospital
  More Information

Additional Information:
Publications:
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.

Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT00755469     History of Changes
Other Study ID Numbers: opt002
Study First Received: September 18, 2008
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Minneapolis Heart Institute Foundation:
Reperfusion injury
Post-Conditioning
Infarct size

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014