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Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study

Sponsor
Ulsan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05389956
Collaborator
(none)
510,000
Enrollment
1
Location
359
Anticipated Duration (Months)
1420.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cancer and cardiovascular disease are the global leading causes of death. These two disease entities are multifactorial disease that are caused by several factors. The aim of this prospective cohort study was to investigate the status of risk factors profiles and health related behavior in Korean population, and to discover novel risk factors associated with the occurrence of endpoint events.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a single center, observational, prospective cohort study. The primary outcomes include the incidence of MACE (major adverse cardiovascular events) and the incidence of any malignancy. We plan to collect the baseline information at enrollment and the occurrence of clinical endpoint events will be followed for at least 10 years. The study will enroll 510,000 subjects aged ≥19 years who underwent a general health screening in Korea.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    510000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2042
    Anticipated Study Completion Date :
    Aug 1, 2052

    Arms and Interventions

    Arm Intervention/Treatment
    Ulsan University Hospital-Health Screening Cohort (UUH-HEALS)

    Ulsan University Hospital-Health Screening Cohort is a prospective cohort of participants who participated in general health screening programs at the Health Promotion Center of Ulsan University Hospital (Ulsan, South Korea). This cohort includes health screening participants aged 19 years and older from community and workplace. The purpose of this cohort is to offer relevant and useful data on health risk factors in the field of non-communicable diseases such as cardiovascular disease and malignancy.

    Outcome Measures

    Primary Outcome Measures

    1. Major adverse cardiovascular event (MACE) [10 year]

      A major adverse cardiovascular event (MACE) of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke

    2. Incidence of malignancy [10 year]

      The occurrence of any malignancy of interest

    Secondary Outcome Measures

    1. All-cause death [10 year]

    2. Cardiovascular death [10 year]

    3. Myocardial infarction [10 year]

    4. Stroke [10 year]

    5. Cancer related mortality [10 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Men or women aged 19 years and older who underwent a general health screening at the health promotion center of Ulsan University Hospital (Ulsan, Korea)

    • Subjects have to agree to participate by signing a consent

    Exclusion Criteria:
    • Subjects who cannot or reject to sign the consent form.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ulsan University Hospital Ulsan Korea, Republic of 44033

    Sponsors and Collaborators

    • Ulsan University Hospital

    Investigators

    • Principal Investigator: Sangwoo Park, MD, Ulsan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sangwoo Park, MD, Ulsan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05389956
    Other Study ID Numbers:
    • 2021-12-014-003
    First Posted:
    May 25, 2022
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    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 Sangwoo Park, MD, Ulsan University Hospital
    Cardiovascular disease
    Malignancy
    Risk factor
    Additional relevant MeSH terms:
    Neoplasms
    Cardiovascular Diseases

    Study Results

    No Results Posted as of May 25, 2022