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Three Dimensional Imaging and Wireless Technologies to Enhance Medical Care in Space (NSBRI #2)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by The Cleveland Clinic.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
National Space Biomedical Research Institute
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00598767
First received: December 26, 2007
Last updated: January 21, 2008
Last verified: January 2008
  Purpose

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


Condition
Aortic Valve Insufficiency
Aortic Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodality 3D Imaging and Wireless Technologies To Enhance Medical Care in Space

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2003
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

In its Bioastronautics Critical Path Roadmap Baseline Document, NASA has outlined the most urgent threats to life and health in manned spaceflight currently in need of countermeasures development. This proposal specifically addresses one of four critical risks directly, that being the risk of trauma and acute medical problems, ID# 43 in the Clinical Capabilities discipline area. Critical for the provision of acute and chronic medical services in space is the availability of high quality diagnostic imaging, with either ground-based or autonomous interpretation. While development of novel sensor technology is actively pursued within the NSBRI, it is clear that for the foreseeable future, the principal diagnostic imaging modality for crew use in space will be ultrasound. For the past six years, the Cleveland Clinic has worked with NASA and NSBRI in a comprehensive program to develop ultrasonographic capabilities for use in manned space flight. Recent work has focused on enhancement of these capabilities, including 3D imaging and novel compression and registration techniques for assessing change over time in ultrasonic images. We now propose to extend these capabilities in very significant ways, capitalizing on dramatic recent advances in telecommunications and computerization to better address the critical countermeasures identified. Among the convergent trends in ultrasound that we seek to capitalize on are the following: most commonly applied diagnostic imaging test; Miniaturization; file storage; telemedicine; wireless telemetry; therapeutic use; real-time 3D.

We propose to extend our work with the following Specific Aims:

  1. Extension of our longstanding research in 3D ultrasound with a recently developed third generation machine small enough to fit on the ISS, allowing more comprehensive imaging to be done with less operator expertise.
  2. Utilization of a ultrafast 3D CT scanner to acquire full body 3D images for segmentation and registration with subsequently acquired 3D ultrasound images, modelling future missions for ground-based 3D CT or MRI could provide a template to judge physiologic or pathologic changes observed in space with 3D ultrasound.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at the Cleveland Clinic undergoing aortic valve repair or replacement
Criteria

Inclusion Criteria:

  • Aortic regurgitation or aortic stenosis and scheduled for repair or replacement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598767

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Space Biomedical Research Institute
Investigators
Principal Investigator: Jim D Thomas, MD The Cleveland Clinic
  More Information

Responsible Party: Jim Thomas, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00598767     History of Changes
Other Study ID Numbers: NSBRI NCC9-59-172 #2  IRB 6403  NSBRI SMS00404 
Study First Received: December 26, 2007
Last Updated: January 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Aortic valve insufficiency
Aortic valve stenosis
3D echocardiogram
3D computed tomography

Additional relevant MeSH terms:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on December 09, 2016