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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Bicuspid Cardiac Valve
• Thoracic Aortic Aneurysm

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