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Sponsors and Collaborators: |
The Cleveland Clinic National Space Biomedical Research Institute |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00598754 |
The purpose of this study is to perform ground-based research to study what happens to the heart muscle in space. People who have problems with their aortic valve have an increase in the amount of muscle in the left ventricle of the heart. After valve surgery, the amount of muscle should decrease and return to normal. Astronauts lose heart muscle mass during space flight. Our study will look at these changes in your heart, which we believe are similar to what happens during long term space travel.
This study will look at the accuracy of three dimensional ultrasound imaging (echo) in monitoring the changes in heart size and function following aortic valve replacement. We are studying ways to prevent health-related problems that men and women will face on long-duration space missions.
The hypothesis is that serial two dimensional and three dimensional echo will show accurate changes in the left ventricle mass and volume following aortic valve replacement for aortic stenosis or regurgitation
Condition |
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Aortic Valve Stenosis Aortic Valve Insufficiency |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Diagnostic Two and Three Dimensional Echocardiography Study Protocol |
Estimated Enrollment: | 40 |
Study Start Date: | June 2001 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Diagnostic Three Dimensional Echocardiography Study Protocol
A. Aims The overall purpose of this study is to perform ground-based research, development, and validation aimed at optimizing diagnostic ultrasound in manned spaceflight, with the following unifying hypothesis: Serial 3D ultrasound examinations will enhance diagnostic capabilities in manned spaceflight.
Specific Aims:
Hypotheses:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients coming to Cleveland Clinic to have surgery for aortic stenosis or aortic insufficiency.
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Jim D Thomas, MD | Cleveland Clinic |
Responsible Party: | Cleveland Clinic ( Jim Thomas, MD ) |
Study ID Numbers: | NSBRI NCC9-59-172 #1, IRB 4401, Cardiac mass regression, 3 dimensional echocardiography, Project # SMS004-004 |
Study First Received: | December 20, 2007 |
Last Updated: | January 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00598754 |
Health Authority: | United States: Institutional Review Board |
Aortic valve stenosis Aortic valve insufficiency Two dimensional echocardiography Three dimensional echocardiography |
Heart Diseases Aortic Valve Insufficiency Constriction, Pathologic |
Aortic valve stenosis Aortic Valve Stenosis Heart Valve Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction |