Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy

NCT04756778 | Completed

• 1 other identifier: IAAinBAVAneurysms2021
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Aortic Aneurysm; Bicuspid Cardiac Valve

Outcome Measures

Primary Outcomes (5)

• Median aortic diameters in aneurysms

  As above

  Data collection period from 27th January 2017 - 15th May 2017

• 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

• 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

• 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 diameter corresponding to aneurysms with IAA >10 cm2/m

  Data collection period from 27th January 2017 - 15th May 2017

Interventions

Aortic surgery +/- aortic valve replacement PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive adult patients undergoing first-time surgery for a BAV-related aneurysm involving the aortic root and/or ascending aorta, between 2010-2016 at our institution

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. George's Hospital, London: lead

Study Sites (1)

St. George's Hospital

London, Middlesex, SW13 0QT, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr Metesh Acharya

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: January 27, 2017
• Primary Completion: May 15, 2017
• Study Completion: August 15, 2017
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)