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Completed

NCT Number: NCT04756778

Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy

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.

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Key information

Conditions

Thoracic Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Bicuspid Cardiac Valve Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. George's Hospital

London, Middlesex, SW13 0QT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aortic surgery +/- aortic valve replacement

Procedure

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

Primary outcomes

  1. Median aortic diameters in aneurysms

    Time frame: Data collection period from 27th January 2017 - 15th May 2017

    As above

  2. 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

  3. 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

  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

    Time frame: Data collection period from 27th January 2017 - 15th May 2017

  5. Median aortic diameter corresponding to aneurysms with IAA >10 cm2/m

    Time frame: Data collection period from 27th January 2017 - 15th May 2017

Sponsors and collaborators

Lead sponsor

St. George's Hospital, London

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 16, 2021
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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