Clinical trial NCT00598767: Three Dimensional Imaging and Wireless Technologies to Enhance Medical Care in Space
Official title: Multimodality 3D Imaging and Wireless Technologies To Enhance Medical Care in Space
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Valve Insufficiency
Aortic Stenosis
Keywords: Aortic valve insufficiency
Aortic valve stenosis
3D echocardiogram
3D computed tomography
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Space Biomedical Research Institute
First posted: 2008-01-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the Cleveland Clinic undergoing aortic valve repair or replacement

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

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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jim D Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: