Reduction of Risk for Cardiovascular Diseases

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05431400
Collaborator
(none)
20,000
2
72
10000
138.9

Study Details

Study Description

Brief Summary

To establish and evaluate a new prediction model for assessing cardiovascular disease risk in community-dwelling adults.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is an ambispective, observational cohort study. In the retrospective part, we will enroll residents from Guangzhou or Foshan who participated in the annual health checks provided by the Chinese National Basic Public Health Service project between January 2015 and December 2019. The demographic characteristics, anthropometric measurements, laboratory assays, medical history, living habits, and medications will be collected through personal electronic health records obtained from the regional chronic disease management platform. In the prospective part, residents who participated in the annual health checks provided by the Chinese National Basic Public Health Service project after January 2020 will be enrolled. In addition to the data collected in the retrospective part, blood, urine and fecal samples and lifestyle questionnaires will be collected for further analysis. All participants will be followed-up till December 2025. A new prediction model for assessing cardiovascular disease risk will be established and evaluated.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Reducing the Risk of Cardiovascular Diseases in Community-dwelling Adults: an Ambispective Cohort Study
    Actual Study Start Date :
    Jan 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Major adverse cardiovascular events [5 years]

      Major adverse cardiovascular events include all-cause mortality, acute myocardial infarction, coronary heart disease, heart failure and stroke.

    Secondary Outcome Measures

    1. Atherosclerotic cardiovascular events [5 years]

      Atherosclerotic cardiovascular events include acute myocardial infarction, coronary heart disease, heart failure and fatal and non-fatal stroke.

    2. All-cause mortality [5 years]

      Defined as any death after enrollment.

    3. Cognitive dysfunction [5 years]

      Defined as Montreal Cognitive Assessment (MoCA) Score < 26 points.

    4. Renal functional deterioration [5 years]

      Evaluated through change in estimated glomerular filtration rate.

    5. Renal replacement therapy and/or death due to acute renal failure [5 years]

    6. Incident atrial fibrillation [5 years]

      Atrial fibrillation is diagnosed according to the 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Meet at least one of the following conditions: 1. Age ≥ 65 years; 2. Diabetes mellitus; 3. Hypertension;
    Exclusion Criteria:
    • Refuse to provide informed consent;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Fourth People's Hospital of Foshan Foshan Guangdong China 528041
    2 Nanfang Hospital, Southern Medical University Guangzhou Guangdong China 510515

    Sponsors and Collaborators

    • Nanfang Hospital of Southern Medical University

    Investigators

    • Principal Investigator: Jiancheng Xiu, MD, Nanfang Hospital of Southern Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nanfang Hospital of Southern Medical University
    ClinicalTrials.gov Identifier:
    NCT05431400
    Other Study ID Numbers:
    • NFEC-2021-083
    First Posted:
    Jun 24, 2022
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nanfang Hospital of Southern Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 24, 2022