A Multicentre Retrospective Study on Bicuspid Aortic Valve

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT05818722
Collaborator
The First Affiliated Hospital with Nanjing Medical University (Other), Nanjing Children's Hospital (Other)
1,000
1
36
27.8

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Multicentre Retrospective Analysis of the Characteristics and the Long-term Prognosis of the Bicuspid Aortic Valve
    Actual Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. All-cause death [1 year]

      Death from any causes

    2. Cardical mortality [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Affiliated Drum Tower Hospital of Nanjing University Medical School Nanjing Jiangsu China 210008

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Jing Yao, Phd, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    ClinicalTrials.gov Identifier:
    NCT05818722
    Other Study ID Numbers:
    • 2022-671
    First Posted:
    Apr 19, 2023
    Last Update Posted:
    Apr 19, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 19, 2023