Analysis of Heart Muscle Function in Patients With Heart Disease and Normal Volunteers
Primary Purpose
Cardiomyopathy, Hypertrophic, Coronary Disease, Healthy
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiomyopathy, Hypertrophic focused on measuring Gated Blood Pool, SPECT Scan, Coronary Artery Disease, Hypertrophic Cardiomyopathy, Microvascular Angina
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.
Sites / Locations
- National Heart, Lung and Blood Institute (NHLBI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001459
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00001459
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
Study Type
Observational
2. Study Status
Record Verification Date
January 2000
Overall Recruitment Status
Completed
Study Start Date
January 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Hypertrophic, Coronary Disease, Healthy, Myocardial Ischemia, Syndrome X
Keywords
Gated Blood Pool, SPECT Scan, Coronary Artery Disease, Hypertrophic Cardiomyopathy, Microvascular Angina
7. Study Design
Enrollment
150 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2785584
Citation
Faber TL, Stokely EM, Templeton GH, Akers MS, Parkey RW, Corbett JR. Quantification of three-dimensional left ventricular segmental wall motion and volumes from gated tomographic radionuclide ventriculograms. J Nucl Med. 1989 May;30(5):638-49.
Results Reference
background
PubMed Identifier
2991357
Citation
Corbett JR, Jansen DE, Lewis SE, Gabliani GI, Nicod P, Filipchuk NG, Redish GA, Akers MS, Wolfe CL, Rellas JS, et al. Tomographic gated blood pool radionuclide ventriculography: analysis of wall motion and left ventricular volumes in patients with coronary artery disease. J Am Coll Cardiol. 1985 Aug;6(2):349-58. doi: 10.1016/s0735-1097(85)80171-6.
Results Reference
background
PubMed Identifier
455620
Citation
Borer JS, Kent KM, Bacharach SL, Green MV, Rosing DR, Seides SF, Epstein SE, Johnston GS. Sensitivity, specificity and predictive accuracy of radionuclide cineangiography during exercise in patients with coronary artery disease. Comparison with exercise electrocardiography. Circulation. 1979 Sep;60(3):572-80. doi: 10.1161/01.cir.60.3.572. No abstract available.
Results Reference
background
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Analysis of Heart Muscle Function in Patients With Heart Disease and Normal Volunteers
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