RESCUE-SCD: REgiStry in Chinese yoUng pEople With Sudden Cardiac Death

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05713240
Collaborator
(none)
450
1
36
12.5

Study Details

Study Description

Brief Summary

The number of sudden cardiac death is up to 540,000 every year in China. Inherited cardiovascular disease is a common cause of sudden cardiac death in young people, and diseases often have the characteristics of family aggregation, so it has a huge psychological and economic burden on family members. Studying the etiology of sudden cardiac death from the molecular level under the model of precision medicine is helpful for screening patients and their relatives so as to further diagnosis, treatment and management, which has important clinical and social significance.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this study, sudden cardiac death and high risk of sudden cardiac death in patients younger than 40 years of age are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography, MRI and other examinations if necessary. The specimens retained include blood or oral swabs for all patients, and myocardium for patients receiving autopsy. Genetic testing will be performed to identify carried disease genes, genetic risk factors and potential therapy targets.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    REgiStry in Chinese yoUng pEople With Sudden Cardiac Death(RESCUE-SCD)
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2025
    Anticipated Study Completion Date :
    Mar 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. number of participants with cardiovascular deaths [an average of 2 years]

      including sudden cardiac death and deaths due to heart failure and stroke

    Secondary Outcome Measures

    1. number of participants with heart failure [an average of 2 years]

      progress to level III or IV in New York Heart Association class

    2. number of participants with stroke [an average of 2 years]

      including cerebral infraction and hemorrhage

    3. number of participants with myocardial infarction [an average of 2 years]

      including ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with sudden cardiac death and sudden unexplained death diagnosed according current practice guidelines.

    • Patients at high risk for sudden cardiac death. (1) Family history of sudden cardiac death at a young age; (2)Successful resuscitation from cardiac arrest; (3) Implantable cardioverter defibrillator implantation after a comprehensive clinical assessment of high risk of sudden cardiac death.

    Exclusion Criteria:
    • Patients who refuse to sign the informed consent or decline follow-up.

    • Patients with sudden death due to car accidents, electric shocks, drowning, fighting, carbon monoxide poisoning and other external causes.

    • Patients with sudden death due to other definite causes, such as cerebrovascular accident, severe kidney disease, respiratory disease, neurological disease, etc.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fuwai hospital Beijing Beijing China 100037

    Sponsors and Collaborators

    • China National Center for Cardiovascular Diseases

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lei.Song,MD.&ph.D, Principal Investigator, Clinical Professor, China National Center for Cardiovascular Diseases
    ClinicalTrials.gov Identifier:
    NCT05713240
    Other Study ID Numbers:
    • RESCUE-SCD
    First Posted:
    Feb 6, 2023
    Last Update Posted:
    Feb 6, 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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 6, 2023