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NCT04756778 Clinical Trial

Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy

Thoracic Aortic Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04756778
Other study ID # IAAinBAVAneurysms2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 27, 2017
Est. completion date August 15, 2017

Study information
Verified date February 2021
Source St. George's Hospital, London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date August 15, 2017
Est. primary completion date May 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Aortic surgery +/- aortic valve replacement
Replacement of aneurysmal proximal thoracic aorta +/- replacement of diseased bicuspid aortic valve

Locations
Country Name City State
United Kingdom St. George's Hospital London Middlesex

Sponsors (1)
Lead Sponsor Collaborator
St. George's Hospital, London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Median aortic diameters in aneurysms As above Data collection period from 27th January 2017 - 15th May 2017
Primary Cross-sectional aortic area/patient height ratio in aneurysms Calculation of indexed aortic area in aneurysms Data collection period from 27th January 2017 - 15th May 2017
Primary Proportion of aneurysms with cross-sectional aortic area/patient height ratio >10 cm2/m Proportion of aneurysms with an abnormal indexed aortic area Data collection period from 27th January 2017 - 15th May 2017
Primary 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 Data collection period from 27th January 2017 - 15th May 2017
Primary Median aortic diameter corresponding to aneurysms with IAA >10 cm2/m Data collection period from 27th January 2017 - 15th May 2017
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