Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight

NCT00598598 | Terminated

• 1 other identifier: NSBRI NCC9-59-172 #3
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Insufficiency; Aortic Valve Stenosis

Keywords

Aortic valve insufficiency; Aortic valve stenosis; 3D echocardiogram

Outcome Measures

Primary Outcomes (1)

• Diagnostic 2D and 3D echocardiography

  6-12 months

Secondary Outcomes (1)

• Endogenous gene expression

  1 week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \> 18 years of age
• Isolated severe aortic stenosis
• Preserved left ventricular function
• CABG patients will have normal LV function and mass

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Space Biomedical Research Institute: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Jim Thomas, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 22, 2008
• Study Start: October 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 12, 2017

Record last verified: 2008-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)