Clinical trial NCT05818722: A Multicentre Retrospective Study on Bicuspid Aortic Valve
Official title: Multicentre Retrospective Analysis of the Characteristics and the Long-term Prognosis of the Bicuspid Aortic Valve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bicuspid Aortic Valve
Keywords: Bicuspid Aortic Valve
Echocardiography
Long-term progress
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: Nanjing Children's Hospital
First posted: 2023-04-19
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Bicuspid Aortic Valve

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 .

Detailed description: Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners, and more than one half of patients require medical or surgical treatment within 20 years of diagnosis. Therefore, early diagnosis and effective treatment can help to reduce the incidence of irreversible cardiac impairment and adverse outcomes such as sudden death. Asian populations with BAV have morphological characteristics that differ from those of the Western populations, and further elucidation of these differences could serve as a guide for the treatment and follow-up of Chinese patients. Based on the above background, We conducted this multicentre retrospective study. We will search for patients diagnosed with BAV by echocardiography or other imaging examinations from December 2021 to October 2022 at Nanjing Gulou Hospital, Jiangsu Provincial Hospital and Nanjing Children's Hospital; collect clinical symptoms, signs and examination results of them; find out the specific surgical plan and time of surgery if they have undergone surgery; follow up for symptoms, medication and reexamin Echocardiography to confirm any endpoint events.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: All-cause death
timeFrame: 1 year
measure: Cardical mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Jing Yao, Phd
role: STUDY_DIRECTOR
References:
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citation: 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.
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