NCT00598754

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2008

Enrollment Period

7 years

First QC Date

December 20, 2007

Last Update Submit

January 10, 2017

Conditions

Aortic Valve StenosisAortic Valve Insufficiency

Keywords

Aortic valve stenosisAortic valve insufficiencyTwo dimensional echocardiographyThree dimensional echocardiography

Outcome Measures

Primary Outcomes (1)

  • Diagnostic 2D and 3D echocardiography

    6 - 12 months

Secondary Outcomes (2)

  • BNP levels

    6-12 months

  • MRI

    6-12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Scheduled for surgery for aortic stenosis or aortic regurgitation

You may not qualify if:

  • Previous open heart surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Jim D Thomas, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 22, 2008

Study Start

June 1, 2001

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

January 11, 2017

Record last verified: 2008-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)