Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight

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

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