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Precision Medicine Study on Cardiovascular Disease (PRECISE)

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04434911
Collaborator
(none)
20,000
Enrollment
1
Location
115
Anticipated Duration (Months)
173.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cardiovascular diseases are the leading cause of death in China and have become a financial burden on society under the traditional medical model. A new and sustainable medical model is needed to solve this dilemma, for which precision medicine models have great potential. Monogenic cardiovascular disease is the first field to be broken through in precision medicine at this stage, and it is also the field where precision medicine is most likely to be successfully transformed into clinical application, including genetic diagnosis, molecular typing, risk stratification, genetic interruption and individualized treatment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this study, patients with monogenic cardiovascular disease 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, saliva, urine and feces for all patients, and myocardium for patients receive cardio myectomy surgery . Genetic testing will be performed to identify novel disease genes, genetic risk factors and potential therapy targets.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Precision Medicine Study on Cardiovascular Disease (PRECISE)
    Anticipated Study Start Date :
    Mar 10, 2021
    Anticipated Primary Completion Date :
    Oct 10, 2025
    Anticipated Study Completion Date :
    Oct 10, 2030

    Outcome Measures

    Primary Outcome Measures

    1. number of participants with cardiovascular deaths [an average of 5 years]

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

    2. number of participants with all-cause death [an average of 5 years.]

      deaths due to all cause.

    Secondary Outcome Measures

    1. number of participants with heart failure [an average of 5 years]

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

    2. number of participants with stroke [an average of 5 years]

      including cerebral infraction and hemorrhage

    3. number of participants with malignant arrhythmia [an average of 5 years]

      including ventricular fibrillation and ventricular tachycardia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with monogenic cardiovascular diagnosed according current practice guideline.
    Exclusion Criteria:
    • Patients who refuse to sign the informed consent or decline follow-up.

    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

    • Principal Investigator: Lei Song, MD. ph.D, Fuwai Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lei.Song@NCCD, Principal Investigator, China National Center for Cardiovascular Diseases
    ClinicalTrials.gov Identifier:
    NCT04434911
    Other Study ID Numbers:
    • PRECISE
    First Posted:
    Jun 17, 2020
    Last Update Posted:
    Mar 9, 2021
    Last Verified:
    Mar 1, 2021
    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 Lei.Song@NCCD, Principal Investigator, China National Center for Cardiovascular Diseases
    monogenic cardiovascular disease
    clinical outcomes
    genomics
    genetic diagnosis
    risk stratification
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Mar 9, 2021