Aortic Valve InsufficiencyNCT00598767
Three Dimensional Imaging and Wireless Technologies to Enhance Medical Care in Space
An observational study of Aortic Valve Insufficiency and Aortic Stenosis, run by The Cleveland Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Insufficiency, Aortic Stenosis
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at the Cleveland Clinic undergoing aortic valve repair or replacement
Who may be able to join
- Aortic regurgitation or aortic stenosis and scheduled for repair or replacement
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodality 3D Imaging and Wireless Technologies To Enhance Medical Care in Space
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
Read the 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:
- 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.
- 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.
- Conditions
- Aortic Valve Insufficiency, Aortic Stenosis
- Keywords
- Aortic valve insufficiency, Aortic valve stenosis, 3D echocardiogram, 3D computed tomography
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2008 (estimated)
- Study startJun 2003
- Primary completionJun 2008
- Study completionJul 2008
Why it stopped: funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Space Biomedical Research Institute
- Responsible party
- Sponsor
- Investigators
- Jim D Thomas, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598767
- Sponsor's protocol ID
- NSBRI NCC9-59-172 #2
- Status last verified
- Jan 2008
- First submitted
- 26 Dec 2007
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality 3D Imaging and Wireless Technologies To Enhance Medical Care in Space
- ClinicalTrials.gov ID
- NCT00598767
- Acronym / sponsor ID
- NSBRI NCC9-59-172 #2
- Conditions
- Aortic Valve Insufficiency, Aortic Stenosis
- Keywords
- Aortic valve insufficiency, Aortic valve stenosis, 3D echocardiogram, 3D computed tomography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: funding issues
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Space Biomedical Research Institute
- Study start
- Jun 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the Cleveland Clinic undergoing aortic valve repair or replacement
Key inclusion criteria (1 listed)
- Aortic regurgitation or aortic stenosis and scheduled for repair or replacement
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: funding issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Insufficiency
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry
Aortic Regurgitation, Aortic Valve Insufficiency
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Not yet recruitingObservational study
Echocardiographic Perspectives on Transient Mitral Regurgitation After Septal Myectomy
Hypertrophic Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim D Thomas, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Insufficiency and Aortic Stenosis, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: funding issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.