Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy

February 11, 2021 updated by: Metesh Acharya, St. George's Hospital, London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Middlesex
      • London, Middlesex, United Kingdom, SW13 0QT
        • St. George's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median aortic diameters in aneurysms
Time Frame: Data collection period from 27th January 2017 - 15th May 2017
As above
Data collection period from 27th January 2017 - 15th May 2017
Cross-sectional aortic area/patient height ratio in aneurysms
Time Frame: Data collection period from 27th January 2017 - 15th May 2017
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
Time Frame: Data collection period from 27th January 2017 - 15th May 2017
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
Time Frame: Data collection period from 27th January 2017 - 15th May 2017
Data collection period from 27th January 2017 - 15th May 2017
Median aortic diameter corresponding to aneurysms with IAA >10 cm2/m
Time Frame: Data collection period from 27th January 2017 - 15th May 2017
Data collection period from 27th January 2017 - 15th May 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. George's Hospital, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 27, 2017

Primary Completion (ACTUAL)

May 15, 2017

Study Completion (ACTUAL)

August 15, 2017

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (ACTUAL)

February 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAAinBAVAneurysms2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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