Brief Title
Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight
Official Title
Echocardiographic Assessment of Cardiovascular Adaptation and Counter Measures n Microgravity
Brief Summary
The National Space Biomedical Research Institute is interested in learning more about heart
function in space. One potential problem with long duration, manned space flight is muscle
loss- including loss of heart muscle. One goal of our research is to help identify why this
muscle loss occurs. We are interested in patients undergoing aortic valve surgery because
this procedure is performed to correct a problem with the valve that may also change heart
function. This change in heart function may provide information that is useful in
understanding and potentially preventing the loss of cardiac muscle in space.
Three patient groups will be studied, patients having surgery for aortic regurgitation,
aortic stenosis, and coronary bypass. We are planing to perform this study on 30 patients, 10
in each group.
The aim of this study is to continue our ongoing study of the magnitude and predictors of the
changes in size of the left ventricle following acute volume and pressure unloading as a
ground-based analog for manned space flight.
Detailed Description
Among the most serious of the risks identified by NASA in the area of cardiovascular
alterations are serious dysrhythmias and the development of orthostatic intolerance.
Prolonged exposure to microgravity may lead to a reduction in cardiac performance,
particularly during times of stress and that undiagnosed cardiovascular disease may manifest
during long missions. The PI and colleagues have worked closely with NASA and NSBRI over the
last six years to optimize use of ultrasound in the space program as an investigative
modality, addressing fundamental cardiovascular problems in need of countermeasures
development. We propose the following specific aim:
To continue our ongoing study of the magnitude and predictors of LV mass regression following
acute volume and pressure unloading as a ground-based analog for manned spaceflight. This
work will continue to focus on patients undergoing aortic valve surgery, but exploit recent
knowledge of the roles of cytokines and integrins involved in cardiac hypertrophy and
regression as well as emerging technologies such as gene chip analysis.
This work will be closely focused on risks and critical questions identified by the
Cardiovascular Alterations Team as described in the Bioastronautics Critical Path Road Map
Baseline Document. If successful, this project will enhance assessment of cardiac function
during long duration missions and potentially suggest cytokine promoters or signal
transduction pathways that could be targeted for cardiac atrophy countermeasures. In
addition, we will continue to provide the facilities of our Core laboratory for access by
investigators throughout the NASA and NSBRI programs in need of assistance in acquiring or
analyzing ultrasonic data.
Study Type
Observational
Primary Outcome
Diagnostic 2D and 3D echocardiography
Secondary Outcome
Endogenous gene expression
Condition
Aortic Valve Insufficiency
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1
Start Date
October 2003
Completion Date
July 2008
Primary Completion Date
June 2008
Eligibility Criteria
Inclusion Criteria:
- > 18 years of age
- Isolated severe aortic stenosis
- Preserved left ventricular function
- CABG patients will have normal LV function and mass
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jim Thomas, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00598598
Organization ID
NSBRI NCC9-59-172 #3
Responsible Party
Sponsor
Study Sponsor
The Cleveland Clinic
Collaborators
National Space Biomedical Research Institute
Study Sponsor
Jim Thomas, MD, Principal Investigator, The Cleveland Clinic
Verification Date
January 2008