Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy

Completed

• Conditions: Thoracic Aortic Aneurysm; Bicuspid Cardiac Valve

• Registration Number: NCT04756778
• Lead Sponsor: St. George's Hospital, London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-27
• Primary Completion: 2017-05-15
• Study Completion: 2017-08-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-11
• Last Update Submitted: 2021-02-11
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

St. George's Hospital; 🇬🇧 London, Middlesex, United Kingdom