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WithdrawnNCT00598754Updated Jan 11, 2017

Diagnostic Three Dimensional Echocardiography Study Protocol

An observational study in Aortic Valve Stenosis and Aortic Valve Insufficiency, sponsored by The Cleveland Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-11.

Sponsored by The Cleveland Clinic · Observational

Why this study was withdrawn
Funding issues
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency

Keywords

  • Aortic valve stenosis
  • Aortic valve insufficiency
  • Two dimensional echocardiography
  • Three dimensional echocardiography
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

Browse Aortic Valve Stenosis studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

  • Scheduled for surgery for aortic stenosis or aortic regurgitation

Exclusion criteria

Exclusion Criteria:

  • Previous open heart surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
06

What researchers measure

Primary outcomes

  1. Diagnostic 2D and 3D echocardiography

    Time frame: 6 - 12 months

Secondary outcomes

  1. BNP levels

    Time frame: 6-12 months

  2. MRI

    Time frame: 6-12 months

07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00598754
Lead sponsor
The Cleveland Clinic
Collaborators
National Space Biomedical Research Institute
Responsible party
Sponsor
First posted
Jan 22, 2008
Start date
Jun 2001
Primary completion
Jun 2008
Completion
Jul 2008
Last update
Jan 11, 2017

Study contacts

Jim D Thomas, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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