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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001459
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
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.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition
Cardiomyopathy, Hypertrophic Coronary Disease Healthy Myocardial Ischemia Syndrome X

Study Type: Observational
Official Title: Tomographic Myocardial Wall Motion Analysis in Patients With Myocardial Ischemia and in Normal Subjects

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 150
Study Start Date: January 1995
Estimated Study Completion Date: March 2001
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  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): NCT00001459


Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001459     History of Changes
Other Study ID Numbers: 950048
95-H-0048
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: January 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Gated Blood Pool
SPECT Scan
Coronary Artery Disease
Hypertrophic Cardiomyopathy
Microvascular Angina

Additional relevant MeSH terms:
Ischemia
Cardiomyopathies
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Hypertrophy
Cardiomyopathy, Hypertrophic
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases