Aortic Valve StenosisNCT02007967
Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation
An observational study of Aortic Valve Stenosis, run by University of Michigan at 1 site in United States.
Trial summary
The overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation (TAVI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jan 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will include patients undergoing clinically indicated computed tomography angiography for evaluation for possible transcatheter aortic valve implantation.
Who may be able to join
- Adults with severe aortic stenosis referred for possible transcatheter aortic valve implantation with clinically indicated computed tomography imaging
Who cannot join
- Inability or unwillingness to consent
- Inability to complete magnetic resonance imaging (MRI) study
- Contraindication to MRI
- Participation in another research study
- Non-diagnostic computed tomography scan
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, 48109
About this study
Official title: Can Non-Contrast Magnetic Resonance Angiography Accurately Define Arterial Access and Aortic Root Anatomy in Patients Referred for Transcatheter Aortic Valve Implantation?
The overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Valve Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal luminal size for aorta and ileofemoral arteries
Compare luminal diameter for each segment of the ileofemoral arteries and aorta between MRI and CT
Measured: 3 hours
Secondary outcomes (2)
Graded image quality
Compare graded image quality for ileofemoral arteries, aorta, and aortic annulus between MRI and CT
Measured: 3 hours
Annular size
Compare annular diameter, area, and perimeter between MRI and CT
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Difficulty enrolling patients
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 University of MichiganThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Troy LaBounty, University of Michigan
- Investigators
- Troy M LaBounty, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007967
- Sponsor's protocol ID
- HUM00070087
- Status last verified
- Dec 2016
- First submitted
- 8 Nov 2013
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Non-Contrast Magnetic Resonance Angiography Accurately Define Arterial Access and Aortic Root Anatomy in Patients Referred for Transcatheter Aortic Valve Implantation?
- ClinicalTrials.gov ID
- NCT02007967
- Acronym / sponsor ID
- HUM00070087
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling patients
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Dec 2013 (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 overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation (TAVI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will include patients undergoing clinically indicated computed tomography angiography for evaluation for possible transcatheter aortic valve implantation.
Key inclusion criteria (1 listed)
- Adults with severe aortic stenosis referred for possible transcatheter aortic valve implantation with clinically indicated computed tomography imaging
Key exclusion criteria (5 listed)
- Inability or unwillingness to consent
- Inability to complete magnetic resonance imaging (MRI) study
- Contraindication to MRI
- Participation in another research study
- Non-diagnostic computed tomography scan
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
Minimal luminal size for aorta and ileofemoral arteries
Time frame: 3 hours
Compare luminal diameter for each segment of the ileofemoral arteries and aorta between MRI and CT
2 secondary outcomes
Graded image quality
Time frame: 3 hours
Annular size
Time frame: 3 hours
Results and safety
The study was stopped early (reason given: Difficulty enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Troy M LaBounty, M.D. principal investigator
University of Michigan
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, run by University of Michigan 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 5 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 22 Dec 2016. 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: Difficulty enrolling patients). 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?
Minimal luminal size for aorta and ileofemoral arteries (time frame: 3 hours). 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 22 Dec 2016.