NCT00598767

Brief Summary

NASA has outlined the most urgent threats to life and health in manned spaceflight. One of the threats is the risk of trauma and acute medical problems. One of the most important provisions of acute and chronic medical services in space is the availability of high quality diagnostic imaging with the potential for either ground based or onsite interpretation. The principle diagnostic imaging modality for space crew use in space will be ultrasound. The aim of the study is as follows:

  • To use state of the art 3 dimensional CT scanner to acquire images for segmentation and registration supplying a template to judge physiologic or pathologic changes observed in space with 3D ultrasound

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
27 days 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 12, 2017

Status Verified

January 1, 2008

Enrollment Period

5 years

First QC Date

December 26, 2007

Last Update Submit

January 10, 2017

Conditions

Aortic Valve InsufficiencyAortic Stenosis

Keywords

Aortic valve insufficiencyAortic valve stenosis3D echocardiogram3D computed tomography

Outcome Measures

Primary Outcomes (1)

  • To use and compare state-of-the-art 3D CT scanner to acquire 3D images for segmentation and registration with subsequent acquired 3D ultrasound images

    6-12 months

Eligibility Criteria

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

Patients at the Cleveland Clinic undergoing aortic valve repair or replacement

You may qualify if:

  • Aortic regurgitation or aortic stenosis and scheduled for repair or replacement

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 InsufficiencyAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Jim D Thomas, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 22, 2008

Study Start

June 1, 2003

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

January 12, 2017

Record last verified: 2008-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)