A Multicentre Retrospective Study on Bicuspid Aortic Valve

NCT05818722 | Unknown

• 1 other identifier: 2022-671
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners. Asian populations with BAV have different morphological characteristics from those of the Western populations, and further elucidation of these differences will serve as a guide for the treatment and follow-up of Asian patients. Therefore, we conducted this multicentre retrospective study to analysis the clinical features, long-term development and surgical prognosis of BAV .

Conditions

Bicuspid Aortic Valve

Keywords

Bicuspid Aortic Valve; Echocardiography; Long-term progress

Outcome Measures

Primary Outcomes (2)

• All-cause death

  Death from any causes

  1 year

• Cardical mortality

  Death due to cardiac disease including MI, arrhythmia, heart failure and aortic lesions

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Bicuspid Aortic Valve

You may qualify if:

• All patients with a suspected diagnosis of Bicuspid Aortic Valve by echocardiogram from December 2021 to October 2022

You may not qualify if:

• Patients with suspected Bicuspid Aortic Valve not clearly diagnosed by echocardiography and not confirmed by cardiac surgery

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Nanjing Children's Hospital: collaborator

Study Sites (1)

Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (5)

• Lee M, Sung J, Cho SJ, Choi SH, Cho SW, Oh JK, Park SJ, Kim DK. Aortic dilatation and calcification in asymptomatic patients with bicuspid aortic valve: analysis in a Korean health screening population. Int J Cardiovasc Imaging. 2013 Mar;29(3):553-60. doi: 10.1007/s10554-012-0116-3. Epub 2012 Aug 26.

  PMID: 22923281 BACKGROUND

• Movahed MR, Hepner AD, Ahmadi-Kashani M. Echocardiographic prevalence of bicuspid aortic valve in the population. Heart Lung Circ. 2006 Oct;15(5):297-9. doi: 10.1016/j.hlc.2006.06.001. Epub 2006 Aug 17.

  PMID: 16914375 BACKGROUND

• Fedak PWM. Bicuspid aortic valve and the specialty clinic: are your patients at risk? Cardiol Young. 2017 Apr;27(3):411-412. doi: 10.1017/S1047951117000282. Epub 2017 Mar 6. No abstract available.

  PMID: 28260551 BACKGROUND

• Lo Presti F, Guzzardi DG, Bancone C, Fedak PWM, Della Corte A. The science of BAV aortopathy. Prog Cardiovasc Dis. 2020 Jul-Aug;63(4):465-474. doi: 10.1016/j.pcad.2020.06.009. Epub 2020 Jun 26.

  PMID: 32599028 BACKGROUND

• Fernandes JF, Gill H, Nio A, Faraci A, Galli V, Marlevi D, Bissell M, Ha H, Rajani R, Mortier P, Myerson SG, Dyverfeldt P, Ebbers T, Nordsletten DA, Lamata P. Non-invasive cardiovascular magnetic resonance assessment of pressure recovery distance after aortic valve stenosis. J Cardiovasc Magn Reson. 2023 Jan 30;25(1):5. doi: 10.1186/s12968-023-00914-3.

  PMID: 36717885 BACKGROUND

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jing Yao, Phd

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY DIRECTOR

Central Study Contacts

Jing Yao, Phd

CONTACT

+8618905188727; w1835199709@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: April 19, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-02

Locations

CN (1)