We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diagnostic Three Dimensional Echocardiography Study Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00598754
Recruitment Status : Withdrawn (Funding issues)
First Posted : January 22, 2008
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

December 20, 2007
January 22, 2008
January 11, 2017
June 2001
June 2008   (Final data collection date for primary outcome measure)
Diagnostic 2D and 3D echocardiography [ Time Frame: 6 - 12 months ]
Same as current
Complete list of historical versions of study NCT00598754 on ClinicalTrials.gov Archive Site
  • BNP levels [ Time Frame: 6-12 months ]
  • MRI [ Time Frame: 6-12 months ]
Same as current
Not Provided
Not Provided
 
Diagnostic Three Dimensional Echocardiography Study Protocol
Diagnostic Two and Three Dimensional Echocardiography Study Protocol

The purpose of this study is to perform ground-based research to study what happens to the heart muscle in space. People who have problems with their aortic valve have an increase in the amount of muscle in the left ventricle of the heart. After valve surgery, the amount of muscle should decrease and return to normal. Astronauts lose heart muscle mass during space flight. Our study will look at these changes in your heart, which we believe are similar to what happens during long term space travel.

This study will look at the accuracy of three dimensional ultrasound imaging (echo) in monitoring the changes in heart size and function following aortic valve replacement. We are studying ways to prevent health-related problems that men and women will face on long-duration space missions.

The hypothesis is that serial two dimensional and three dimensional echo will show accurate changes in the left ventricle mass and volume following aortic valve replacement for aortic stenosis or regurgitation

Diagnostic Three Dimensional Echocardiography Study Protocol

A. Aims The overall purpose of this study is to perform ground-based research, development, and validation aimed at optimizing diagnostic ultrasound in manned spaceflight, with the following unifying hypothesis: Serial 3D ultrasound examinations will enhance diagnostic capabilities in manned spaceflight.

Specific Aims:

  1. To optimize acquisition methods for 3D sonography using reconstruction and real-time techniques
  2. To determine the utility of serial 3D ultrasound examinations in identifying renal calculi and their complications including the development and resolution of hydronephrosis and calyceal dilatation.
  3. To determine the utility of serial 2D and 3D ultrasound examinations in demonstrating cardiac remodeling (changes in cardiac dimensions, volume, mass and function) and defining its determinants after left ventricular unloading following aortic valve replacement for aortic stenosis or regurgitation.
  4. To determine whether changes in plasma BNP levels accurately reflect changes in LV mass and volume.

Hypotheses:

  1. Serial 3D ultrasound examinations will allow accurate diagnosis of nephrolithiasis and tracking of complications including hydronephrosis and calyceal dilatation
  2. Serial 2D and 3D ultrasound will allow accurate tracking of changes in LV mass and volume following aortic valve replacement (AVR) for aortic stenosis or regurgitation.
  3. Changes in plasma BNP levels will fall in proportion to the decrease in LV mass and volume.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients coming to Cleveland Clinic to have surgery for aortic stenosis or aortic insufficiency.
  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2008
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled for surgery for aortic stenosis or aortic regurgitation

Exclusion Criteria:

  • Previous open heart surgery
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00598754
NSBRI NCC9-59-172 #1
IRB 4401
Cardiac mass regression
3 dimensional echocardiography
Project # SMS004-004
No
Not Provided
Plan to Share IPD: No
The Cleveland Clinic
The Cleveland Clinic
National Space Biomedical Research Institute
Principal Investigator: Jim D Thomas, MD The Cleveland Clinic
The Cleveland Clinic
January 2008