Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight

Sponsor
The Cleveland Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT00598598
Collaborator
National Space Biomedical Research Institute (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Echocardiographic Assessment of Cardiovascular Adaptation and Counter Measures n Microgravity
    Study Start Date :
    Oct 1, 2003
    Actual Primary Completion Date :
    Jun 1, 2008
    Actual Study Completion Date :
    Jul 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic 2D and 3D echocardiography [6-12 months]

    Secondary Outcome Measures

    1. Endogenous gene expression [1 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18 years of age

    • Isolated severe aortic stenosis

    • Preserved left ventricular function

    • CABG patients will have normal LV function and mass

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • The Cleveland Clinic
    • National Space Biomedical Research Institute

    Investigators

    • Principal Investigator: Jim Thomas, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT00598598
    Other Study ID Numbers:
    • NSBRI NCC9-59-172 #3
    First Posted:
    Jan 22, 2008
    Last Update Posted:
    Jan 12, 2017
    Last Verified:
    Jan 1, 2008
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by The Cleveland Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2017