Three Dimensional Imaging and Wireless Technologies to Enhance Medical Care in Space

Aortic Stenosis Clinical Trial

Official title:

Multimodality 3D Imaging and Wireless Technologies To Enhance Medical Care in Space

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00598767
• Other study ID #: NSBRI NCC9-59-172 #2
• Status: Terminated
• Phase: N/A
• First received: December 26, 2007
• Last updated: January 10, 2017
• Start date: June 2003
• Est. completion date: July 2008

Study information

• Verified date: January 2008
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Space Biomedical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No