Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight (NSBRI#3)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by The Cleveland Clinic.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Space Biomedical Research Institute
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00598598
First received: December 27, 2007
Last updated: January 21, 2008
Last verified: January 2008
  Purpose

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
Aortic Valve Insufficiency
Aortic Valve Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Echocardiographic Assessment of Cardiovascular Adaptation and Counter Measures n Microgravity

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Diagnostic 2D and 3D echocardiography [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endogenous gene expression [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2003
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients coming to the Cleveland Clinic with aortic valve insufficiency or aortic valve stenosis, undering going repair or replacement, or patient undergoing coronary bypass surgery.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598598

Contacts
Contact: Roberta Palumbo, RN 216-444-8774 palumbr@ccf.org
Contact: Christine Reynolds, RN 216-445-6916 whitmac@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Roberta Palumbo, RN    216-444-8778    palumbr@ccf.org   
Contact: Christine Whitman, RN    216-445-6916    whitmac@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
National Space Biomedical Research Institute
Investigators
Principal Investigator: Jim Thomas, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Jim Thomas, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00598598     History of Changes
Other Study ID Numbers: NSBRI NCC9-59-172 #3, IRB 6414, NSBRI SMS00404
Study First Received: December 27, 2007
Last Updated: January 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Aortic valve insufficiency
Aortic valve stenosis
3D echocardiogram

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 25, 2014