Aortic Valve StenosisNCT00598754
Diagnostic Three Dimensional Echocardiography Study Protocol
An observational study of Aortic Valve Stenosis and Aortic Valve Insufficiency, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to perform ground-based research to study what happens to the heart muscle in space. People who have problems with their aortic valve have an increase in the amount of muscle in the left ventricle of the heart. After valve surgery, the amount of muscle should decrease and return to normal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to 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 coming to Cleveland Clinic to have surgery for aortic stenosis or aortic insufficiency.
Who may be able to join
- Scheduled for surgery for aortic stenosis or aortic regurgitation
Who cannot join
- Previous open heart surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Two and Three Dimensional Echocardiography Study Protocol
The purpose of this study is to perform ground-based research to study what happens to the heart muscle in space. People who have problems with their aortic valve have an increase in the amount of muscle in the left ventricle of the heart. After valve surgery, the amount of muscle should decrease and return to normal. Astronauts lose heart muscle mass during space flight. Our study will look at these changes in your heart, which we believe are similar to what happens during long term space travel.
This study will look at the accuracy of three dimensional ultrasound imaging (echo) in monitoring the changes in heart size and function following aortic valve replacement. We are studying ways to prevent health-related problems that men and women will face on long-duration space missions.
The hypothesis is that serial two dimensional and three dimensional echo will show accurate changes in the left ventricle mass and volume following aortic valve replacement for aortic stenosis or regurgitation
Read the detailed description
Diagnostic Three Dimensional Echocardiography Study Protocol
- Aims The overall purpose of this study is to perform ground-based research, development, and validation aimed at optimizing diagnostic ultrasound in manned spaceflight, with the following unifying hypothesis: Serial 3D ultrasound examinations will enhance diagnostic capabilities in manned spaceflight.
Specific Aims:
- To optimize acquisition methods for 3D sonography using reconstruction and real-time techniques
- To determine the utility of serial 3D ultrasound examinations in identifying renal calculi and their complications including the development and resolution of hydronephrosis and calyceal dilatation.
- To determine the utility of serial 2D and 3D ultrasound examinations in demonstrating cardiac remodeling (changes in cardiac dimensions, volume, mass and function) and defining its determinants after left ventricular unloading following aortic valve replacement for aortic stenosis or regurgitation.
- To determine whether changes in plasma BNP levels accurately reflect changes in LV mass and volume.
Hypotheses:
- Serial 3D ultrasound examinations will allow accurate diagnosis of nephrolithiasis and tracking of complications including hydronephrosis and calyceal dilatation
- Serial 2D and 3D ultrasound will allow accurate tracking of changes in LV mass and volume following aortic valve replacement (AVR) for aortic stenosis or regurgitation.
- Changes in plasma BNP levels will fall in proportion to the decrease in LV mass and volume.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Keywords
- Aortic valve stenosis, Aortic valve insufficiency, Two dimensional echocardiography, Three dimensional echocardiography
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic 2D and 3D echocardiography
Measured: 6 - 12 months
Secondary outcomes (2)
BNP levels
Measured: 6-12 months
MRI
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 2001
- 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 StenosisStudies 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
- 0 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
- NCT00598754
- Sponsor's protocol ID
- NSBRI NCC9-59-172 #1
- Other IDs
- IRB 4401, Cardiac mass regression, 3 dimensional echocardiography, Project # SMS004-004
- Status last verified
- Jan 2008
- First submitted
- 20 Dec 2007
- Last updated
- 11 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 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Two and Three Dimensional Echocardiography Study Protocol
- ClinicalTrials.gov ID
- NCT00598754
- Acronym / sponsor ID
- NSBRI NCC9-59-172 #1
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Keywords
- Aortic valve stenosis, Aortic valve insufficiency, Two dimensional echocardiography, Three dimensional echocardiography
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Space Biomedical Research Institute
- Study start
- Jun 2001
- 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.
The purpose of this study is to perform ground-based research to study what happens to the heart muscle in space. People who have problems with their aortic valve have an increase in the amount of muscle in the left ventricle of the heart. After valve surgery, the amount of muscle should decrease and return to normal. Astronauts lose heart muscle mass during space flight. Our study will look at these changes in your heart, which we believe are similar to what happens during long term space travel.
This study will look at the accuracy of three dimensional ultrasound imaging (echo) in monitoring the changes in heart size and function following aortic valve replacement. We are studying ways to prevent health-related problems that men and women will face on long-duration space missions.
The hypothesis is that serial two dimensional and three dimensional echo will show accurate changes in the left ventricle mass and volume following aortic valve replacement for aortic stenosis or regurgitation
Detailed description
Diagnostic Three Dimensional Echocardiography Study Protocol
- Aims The overall purpose of this study is to perform ground-based research, development, and validation aimed at optimizing diagnostic ultrasound in manned spaceflight, with the following unifying hypothesis: Serial 3D ultrasound examinations will enhance diagnostic capabilities in manned spaceflight.
Specific Aims:
- To optimize acquisition methods for 3D sonography using reconstruction and real-time techniques
- To determine the utility of serial 3D ultrasound examinations in identifying renal calculi and their complications including the development and resolution of hydronephrosis and calyceal dilatation.
- To determine the utility of serial 2D and 3D ultrasound examinations in demonstrating cardiac remodeling (changes in cardiac dimensions, volume, mass and function) and defining its determinants after left ventricular unloading following aortic valve replacement for aortic stenosis or regurgitation.
- To determine whether changes in plasma BNP levels accurately reflect changes in LV mass and volume.
Hypotheses:
- Serial 3D ultrasound examinations will allow accurate diagnosis of nephrolithiasis and tracking of complications including hydronephrosis and calyceal dilatation
- Serial 2D and 3D ultrasound will allow accurate tracking of changes in LV mass and volume following aortic valve replacement (AVR) for aortic stenosis or regurgitation.
- Changes in plasma BNP levels will fall in proportion to the decrease in LV mass and volume.
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 coming to Cleveland Clinic to have surgery for aortic stenosis or aortic insufficiency.
Key inclusion criteria (1 listed)
- Scheduled for surgery for aortic stenosis or aortic regurgitation
Key exclusion criteria (1 listed)
- Previous open heart surgery
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
Diagnostic 2D and 3D echocardiography
Time frame: 6 - 12 months
2 secondary outcomes
BNP levels
Time frame: 6-12 months
MRI
Time frame: 6-12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Individual participant dataSharing planned: No
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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 Stenosis and Aortic Valve Insufficiency, 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 1 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: withdrawn, as of the sponsor's last update on 11 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 withdrawn before enrolling participants, so there are no results.
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?
Diagnostic 2D and 3D echocardiography (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 11 Jan 2017.