Thoracic Aortic AneurysmNCT04756778
Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy
An observational study of Thoracic Aortic Aneurysm and Bicuspid Cardiac Valve, run by St. George's Hospital, London at 1 site in United Kingdom.
Trial summary
This study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysm, Bicuspid Cardiac Valve
- What is being tested?
- Aortic surgery +/- aortic valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jan 2017to 15 Aug 2017
- 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: All consecutive adult patients undergoing first-time surgery for a BAV-related aneurysm involving the aortic root and/or ascending aorta, between 2010-2016 at our institution
Who may be able to join
- Age >18 years
- First-time surgery
- Bicuspid aortic valve confirmed
- Thoracic aortic aneurysm involving aortic root or ascending aorta
Who cannot join
- No available pre-operative cross-sectional imaging
- Re-do surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Indexed Aortic Area and Aortic Diameter in Bicuspid Aortic Valve Aortopathy: A Retrospective Cohort Study
This study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve. This will shed light on whether aneurysms with smaller diameters than those recommended for surgical intervention by guidelines are still at risk of aortic complications attending an abnormally high indexed aortic area.
- Conditions
- Thoracic Aortic Aneurysm, Bicuspid Cardiac Valve
- Being tested
- Aortic surgery +/- aortic valve replacement
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic surgery +/- aortic valve replacementProcedure or surgery
Replacement of aneurysmal proximal thoracic aorta +/- replacement of diseased bicuspid aortic valve
What is being measured
The primary outcome is the main question the study is designed to answer.
Median aortic diameters in aneurysms
As above
Measured: Data collection period from 27th January 2017 - 15th May 2017
Cross-sectional aortic area/patient height ratio in aneurysms
Calculation of indexed aortic area in aneurysms
Measured: Data collection period from 27th January 2017 - 15th May 2017
Proportion of aneurysms with cross-sectional aortic area/patient height ratio >10 cm2/m
Proportion of aneurysms with an abnormal indexed aortic area
Measured: Data collection period from 27th January 2017 - 15th May 2017
Median cross-sectional aortic area/patient height ratio for aneurysms with diameter <4.0 cm, 4.0-4.5 cm, 4.5-5.0 cm, 5.0-5.5 cm and >5.5 cm
Measured: Data collection period from 27th January 2017 - 15th May 2017
Median aortic diameter corresponding to aneurysms with IAA >10 cm2/m
Measured: Data collection period from 27th January 2017 - 15th May 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start27 Jan 2017
- Primary completion15 May 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. George's Hospital, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metesh Acharya, St. George's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756778
- Sponsor's protocol ID
- IAAinBAVAneurysms2021
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Indexed Aortic Area and Aortic Diameter in Bicuspid Aortic Valve Aortopathy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04756778
- Acronym / sponsor ID
- IAAinBAVAneurysms2021
- Conditions
- Thoracic Aortic Aneurysm, Bicuspid Cardiac Valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- St. George's Hospital, LondonUniversity, hospital or other
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 16 Feb 2021 (actual)
- 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.
This study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve. This will shed light on whether aneurysms with smaller diameters than those recommended for surgical intervention by guidelines are still at risk of aortic complications attending an abnormally high indexed aortic area.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients undergoing first-time surgery for a BAV-related aneurysm involving the aortic root and/or ascending aorta, between 2010-2016 at our institution
Key inclusion criteria (4 listed)
- Age >18 years
- First-time surgery
- Bicuspid aortic valve confirmed
- Thoracic aortic aneurysm involving aortic root or ascending aorta
Key exclusion criteria (2 listed)
- No available pre-operative cross-sectional imaging
- Re-do surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic surgery +/- aortic valve replacementReplacement of aneurysmal proximal thoracic aorta +/- replacement of diseased bicuspid aortic valve | Procedure or surgery | – |
Primary outcome
Median aortic diameters in aneurysms
Time frame: Data collection period from 27th January 2017 - 15th May 2017
As above
Cross-sectional aortic area/patient height ratio in aneurysms
Time frame: Data collection period from 27th January 2017 - 15th May 2017
Calculation of indexed aortic area in aneurysms
Proportion of aneurysms with cross-sectional aortic area/patient height ratio >10 cm2/m
Time frame: Data collection period from 27th January 2017 - 15th May 2017
Proportion of aneurysms with an abnormal indexed aortic area
Median cross-sectional aortic area/patient height ratio for aneurysms with diameter <4.0 cm, 4.0-4.5 cm, 4.5-5.0 cm, 5.0-5.5 cm and >5.5 cm
Time frame: Data collection period from 27th January 2017 - 15th May 2017
Median aortic diameter corresponding to aneurysms with IAA >10 cm2/m
Time frame: Data collection period from 27th January 2017 - 15th May 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thoracic Aortic Aneurysm and Bicuspid Cardiac Valve, run by St. George's Hospital, London at 1 site in United Kingdom.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 16 Feb 2021. 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 Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Median aortic diameters in aneurysms (time frame: Data collection period from 27th January 2017 - 15th May 2017). The study lists 5 primary outcomes in all. 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 16 Feb 2021.