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Heart Muscle Viability and Remodeling in Individuals Post-Heart Attack

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099411
First Posted: December 14, 2004
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Tufts Medical Center
  Purpose
The purpose of this study is to assess the effect of heart muscle viability on left ventricular (LV) remodeling after a heart attack; to explore the relationships between retained viability of the area of tissue death (infarct zone), LV remodeling, response to the Occluded Artery Trial (OAT) intervention, and response to late percutaneous coronary intervention of the infarct related artery (IRA).

Condition
Cardiovascular Diseases Coronary Disease Myocardial Infarction Heart Diseases Heart Failure, Congestive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myocardial Viability and Remodeling in the Occluded Artery Trial (OAT)-Ancillary to OAT

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year. [ Time Frame: 1 year ]
    The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year.


Enrollment: 124
Actual Study Start Date: January 2004
Study Completion Date: June 30, 2007
Primary Completion Date: June 30, 2007 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Coronary heart disease is a major health problem in the United States. It is estimated that in 2003, more than 600,000 Americans had a new heart attack, and more than 400,000 experienced a recurrent heart attack. Up to 40% of individuals with a new or recurrent heart attack will show a complete occlusion, or blocking, of the IRA on follow-up angiography. Many people with an occluded IRA post-heart attack are at risk for progressive LV remodeling in the heart, which can lead to congestive heart failure.

The NHLBI-funded OAT study is testing the hypothesis that opening an occluded IRA 3 to 28 days following a heart attack will reduce the composite endpoint of mortality, recurrent heart attack, and New York Heart Association class IV heart failure over a three-year follow-up period. OAT has enrolled approximately 1,100 participants at 240 centers in 24 countries. Among the mechanisms proposed to explain the benefit of late revascularization, recovery of LV function and attenuation of LV remodeling due to restoration of blood flow to viable myocardium, or heart muscle, is the most plausible.

DESIGN NARRATIVE:

An estimated 200 individuals who have had a heart attack will be enrolled in this study. The primary aims of this study are the following: 1) to test the hypothesis that participants who demonstrate preservation of viability within the infarct zone will have less progressive remodeling compared to participants exhibiting predominant infarct, and 2) to test the hypothesis that preservation of viability will modify the treatment effect of randomization to late revascularization in participants with an occluded IRA 3 to 28 days after the heart attack. All participants will have resting gated Tc-99m sestamibi SPECT imaging at baseline, and again 1 year later. Parameters of baseline viability within the infarct zone, and serial measures of LV volume change and function will be centrally assessed by the Cardiac Imaging Core Laboratory at Tufts Medical Center. The major study endpoint to address the hypotheses will be serial change in LV end-diastolic volume, based on the degree of preservation of viability within the defined infarct zone. Sample size calculations will be based on data evaluated by the same group from a similar number of participants studied at a similar number of clinical sites.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People who have experienced a heart attack 3 to 28 days prior to study entry.
Criteria

Inclusion Criteria:

  • Has experienced a heart attack 3 to 28 days prior to study entry
  • Has an occluded IRA at catheterization
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099411


Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 10010
Sponsors and Collaborators
Tufts Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: James E. Udelson Tufts Medical Center
  More Information

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00099411     History of Changes
Other Study ID Numbers: 1279
R01HL075456 ( U.S. NIH Grant/Contract )
First Submitted: December 13, 2004
First Posted: December 14, 2004
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases


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