Diagnostic Three Dimensional Echocardiography Study Protocol

NCT ID: NCT00598754

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2008-07-31

Brief 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

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Scheduled for surgery for aortic stenosis or aortic regurgitation

Exclusion Criteria

• Previous open heart surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Space Biomedical Research Institute

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jim D Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

IRB 4401

Identifier Type: -

Identifier Source: secondary_id

Cardiac mass regression

Identifier Type: -

Identifier Source: secondary_id

3 dimensional echocardiography

Identifier Type: -

Identifier Source: secondary_id

Project # SMS004-004

Identifier Type: -

Identifier Source: secondary_id

NSBRI NCC9-59-172 #1

Identifier Type: -

Identifier Source: org_study_id