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Diagnostic Three Dimensional Echocardiography Study Protocol (NSBRI 4401)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Space Biomedical Research Institute
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00598754
First received: December 20, 2007
Last updated: January 21, 2008
Last verified: January 2008
History of Changes
  Purpose

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


Condition
Aortic Valve Stenosis
Aortic Valve Insufficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Two and Three Dimensional Echocardiography Study Protocol

Resource links provided by NLM:

U.S. FDA Resources

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:
  • BNP levels [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • MRI [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2001
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.
  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 Cleveland Clinic to have surgery for aortic stenosis or aortic insufficiency.

Criteria

Inclusion Criteria:

  • Scheduled for surgery for aortic stenosis or aortic regurgitation

Exclusion Criteria:

  • Previous open heart surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598754

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Space Biomedical Research Institute
Investigators
Principal Investigator: Jim D Thomas, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Jim Thomas, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00598754     History of Changes
Other Study ID Numbers: NSBRI NCC9-59-172 #1, IRB 4401, Cardiac mass regression, 3 dimensional echocardiography, Project # SMS004-004
Study First Received: December 20, 2007
Last Updated: January 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Aortic valve stenosis
Aortic valve insufficiency
Two dimensional echocardiography
Three dimensional echocardiography

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 May 19, 2013