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

Study Overview

• Status: Withdrawn
• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Scheduled for surgery for aortic stenosis or aortic regurgitation

Exclusion Criteria:

• Previous open heart surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic 2D and 3D echocardiography	6 - 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
BNP levels	6-12 months
MRI	6-12 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: National Space Biomedical Research Institute
• Investigators: Principal Investigator: Jim D Thomas, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: January 21, 2008
• First Posted (Estimate): January 22, 2008

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Aortic valve stenosis; Aortic valve insufficiency; Two dimensional echocardiography; Three dimensional echocardiography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: NSBRI NCC9-59-172 #1; IRB 4401; Cardiac mass regression; 3 dimensional echocardiography; Project # SMS004-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO