Diagnostic Three Dimensional Echocardiography Study Protocol

Aortic Valve Stenosis Clinical Trial

Official title:

Diagnostic Two and Three Dimensional Echocardiography Study Protocol

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00598754
• Other study ID #: NSBRI NCC9-59-172 #1
• Secondary ID: IRB 4401Cardiac
• Status: Withdrawn
• Phase: N/A
• First received: December 20, 2007
• Last updated: January 10, 2017
• Start date: June 2001
• Est. completion date: July 2008

Study information

• Verified date: January 2008
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for surgery for aortic stenosis or aortic regurgitation

Exclusion Criteria:

• Previous open heart surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Space Biomedical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic 2D and 3D echocardiography		6 - 12 months	No
Secondary	BNP levels		6-12 months	No
Secondary	MRI		6-12 months	No