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Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy

Relationship Between Indexed Aortic Area and Aortic Diameter in Bicuspid Aortic Valve Aortopathy: A Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04756778
Enrollment
69
Registered
2021-02-16
Start date
2017-01-27
Completion date
2017-08-15
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bicuspid Cardiac Valve, Thoracic Aortic Aneurysm

Brief 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. 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.

Interventions

PROCEDUREAortic surgery +/- aortic valve replacement

Replacement of aneurysmal proximal thoracic aorta +/- replacement of diseased bicuspid aortic valve

Sponsors

St. George's Hospital, London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>18 years * First-time surgery * Bicuspid aortic valve confirmed * Thoracic aortic aneurysm involving aortic root or ascending aorta

Exclusion criteria

* No available pre-operative cross-sectional imaging * Re-do surgery

Design outcomes

Primary

MeasureTime frameDescription
Median aortic diameter corresponding to aneurysms with IAA >10 cm2/mData collection period from 27th January 2017 - 15th May 2017
Median aortic diameters in aneurysmsData collection period from 27th January 2017 - 15th May 2017As above
Cross-sectional aortic area/patient height ratio in aneurysmsData collection period from 27th January 2017 - 15th May 2017Calculation of indexed aortic area in aneurysms
Proportion of aneurysms with cross-sectional aortic area/patient height ratio >10 cm2/mData collection period from 27th January 2017 - 15th May 2017Proportion 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 cmData collection period from 27th January 2017 - 15th May 2017

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026