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Analysis of Heart Muscle Function in Patients With Heart Disease and Normal Volunteers

This study has been completed.
Study NCT00001459.   Last updated on March 3, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  Analysis of Heart Muscle Function in Patients With Heart Disease and Normal Volunteers
Official Title  Tomographic Myocardial Wall Motion Analysis in Patients With Myocardial Ischemia and in Normal Subjects
Brief Summary

Myocardial ischemia is a heart condition in which not enough blood supply and oxygen reaches the heart muscle. Damage to the major blood vessels of the heart (coronary artery disease), minor blood vessels of the heart (microvascular heart disease), or damage to the heart muscle (hypertrophic cardiomyopathy) can cause myocardial ischemia. Any of theses three conditions can cause patients to experience chest pain and other symptoms as well as cause the heart to function improperly.

In order to detect myocardial ischemia researchers can use tests to measure the movement of the walls of the heart. Walls receiving inadequate supplies of blood often move less and occasionally move in the opposite direction. Some of the tests may require patients to receive injections of radioactive tracers. The radioactive material acts to enhance 3 dimensional pictures of the heart and helps to identify areas of ischemia.

The purpose of this study is to determine whether 3-dimensional imaging (tomography) with radioactive tracers can provide more important information about heart wall function than routine diagnostic tests.

Detailed Description

We propose to assess regional myocardial function using gated blood pool imaging acquired by a tomographic technique at rest and during stress in patients with myocardial ischemia (coronary artery disease, hypertrophic cardiomyopathy and microvascular angina). Gender differences in response to exercise and pharmacologic stress will also be evaluated. Normal subjects will be studied in order to establish a control database. Current methods of gated blood pool studies use planar imaging, with its attendant limitations; poor resolution and inadequate separation of the myocardial segments, only one view assessed during exercise and superimposition of overlying structures. Tomographic imaging has the advantages of reconstructing 3-dimensional data of the entire heart with the ability to improve segmental resolution and separate overlapping structures, potentially resulting in increased sensitivity and specificity for detection of disease.

The role of pharmacologic stress will be assessed by comparison with exercise stress, in order to validate its use in subjects unable to exercise and identify gender related differences. Quantitative measures of regional wall motion obtained from tomography will be compared to regions of prior myocardial infarction (if present), and with other modalities for evaluating cardiac structure and function. The diagnostic and prognostic value of tomographic wall motion analysis will be studied in patients with myocardial ischemia, with special emphasis on correlation between physiologic variables of coronary blood flow and metabolic function.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cardiomyopathy, Hypertrophic
Coronary Disease
Healthy
Myocardial Ischemia
Syndrome X
Intervention 
MEDLINE PMIDs 2785584,   2991357,   455620
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  150
Start Date  January 1995
Completion Date March 2001
Eligibility Criteria 

Patients with known coronary artery disease (obstruction of greater than or equal to 50% in at least one major coronary artery).

Patients with hypertrophic cardiomyopathy.

Patients with microvascular angina.

No unstable angina.

No hepatic or renal failure.

Infective endocarditis

No primary valvular disease.

No congenital heart disease.

No pregnant or breast feeding women.

Gender Both
Ages
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001459
Organization ID 950048
Secondary IDs †† 95-H-0048
Study Sponsor  National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date January 2000
First Received Date  November 3, 1999
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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