Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy

• Sponsor: St. George's Hospital, London (Other)
• Overall Status: Completed
• CT.gov ID: NCT04756778
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 10.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Aortic Aneurysm; Bicuspid Cardiac Valve	Procedure: Aortic surgery +/- aortic valve replacement

Study Design

• Study Type: Observational
• Actual Enrollment: 69 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Relationship Between Indexed Aortic Area and Aortic Diameter in Bicuspid Aortic Valve Aortopathy: A Retrospective Cohort Study
• Actual Study Start Date: Jan 27, 2017
• Actual Primary Completion Date: May 15, 2017
• Actual Study Completion Date: Aug 15, 2017

Outcome Measures

Primary Outcome Measures

1. Median aortic diameters in aneurysms [Data collection period from 27th January 2017 - 15th May 2017]

   As above

2. 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

3. 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

4. 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]

5. Median aortic diameter corresponding to aneurysms with IAA >10 cm2/m [Data collection period from 27th January 2017 - 15th May 2017]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. George's Hospital	London	Middlesex	United Kingdom	SW13 0QT

Sponsors and Collaborators

• St. George's Hospital, London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Metesh Acharya, Mr Metesh Acharya, St. George's Hospital, London
• ClinicalTrials.gov Identifier: NCT04756778
• Other Study ID Numbers: IAAinBAVAneurysms2021
• First Posted: Feb 16, 2021
• Last Update Posted: Feb 16, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Bicuspid Aortic Valve Disease; Aortic Aneurysm, Thoracic

Study Results

No Results Posted as of Feb 16, 2021