The Qingdao Port Health Study

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Completed
CT.gov ID
NCT02329886
Collaborator
(none)
25,000
34

Study Details

Study Description

Brief Summary

China, efforts are underway to respond to an unprecedented epidemiologic transition, with soaring rates of cardiovascular disease (CVD), including heart disease and stroke. Yet there may be limitations in translating observations and findings derived from Anglo-based population studies. As such, there is a critical need for population-based studies that provide insight into the risk factors, incidence, and outcomes of CVD in China. The Qingdao Port Health Study is a population-based prospective cohort study of employees of the Qingdao Port Group, China, designed to investigate the burden of CVD and risk factors (e.g., sociodemographic, biological, environmental and clinical factors) associated with disease onset and outcomes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In Qingdao Port, annual health assessments are offered at 3 on-site health clinics. The annual health assessment consists of a questionnaire, physical examination, laboratory tests, bio-sampling, and imaging examinations.In each year, demographics information, medical history, medication use and adherence, family history,lifestyles (e.g., nutritional intake; physical activity; smoking; alcohol use/abuse), menopause (including hormone use) and quality of life were collected by trained researchers.In 2013, blood and saliva samples were collected. Follow-up health assessments are performed every year. The outcomes of cardiovascular disease (angina, myocardial infarction, heart failure, stroke, revascularization), non-communicable diseases (chronic obstructive pulmonary disease, renal failure, liver disease and cancer), and all-cause death are collected from local medical insurance database.This study aim to surveillance of cardiovascular and other non-communicable diseases (risk factors, health outcomes and trends) and investigate of socio-cultural, biological, behavioral, social, and environmental factors on work performance, cardiovascular disease onset and cardiovascular health outcomes.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Qingdao Port Health Study
    Study Start Date :
    Mar 1, 2013
    Actual Primary Completion Date :
    Jan 1, 2016
    Actual Study Completion Date :
    Jan 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. all cause mortality [3 year]

      The number of all cause death will be collected. The effects of modified risk factors on all cause mortality will be assessed.

    Secondary Outcome Measures

    1. Heart diseases (defined as myocardial infarction, agina requiring hospitalization and acute/chronic heart failure) [3 year]

      The number of heart disease outcomes will be collected because one person may have more than one time heart diseases. The incidence of heart disease is calculated by dividing the number of heart disease outcomes by the total number of participants in baseline study.

    2. stroke (defined as ischemic stroke and hemorraghic stroke) [3 year]

      The number of stroke outcomes will be collected. The incidence of stroke is calculated by dividing the number of stroke outcomes by the total number of participants in baseline study.

    3. revascularization (defined as percutaneous coronary intervention, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty) [3 year]

      The number of revascularizations will be collected, one person may receive more than one time revascularizations. The incidence of revascularization is calculated by dividing the number of revascularization outcomes by the total number of participants in baseline study.

    Other Outcome Measures

    1. chronic obstructive pulmonary disease [3 year]

      The number of participants with chronic obstructive pulmonary disease (COPD) will be collected. The incidence of COPD is calculated by dividing the number of COPD by the total number of participants in baseline study.

    2. chronic renal insufficiency [3 year]

      The number of participants with chronic renal insufficiency will be collected. The incidence of chronic renal insufficiency is calculated by dividing the number of chronic renal insufficiency by the total number of participants in baseline study.

    3. chronic liver diseases (defined as cirrhosis and hepatic failure) [3 year]

      The number of chronic liver diseases will be collected. The incidence of chronic liver diseases is calculated by dividing the number of chronic liver diseases by the total number of participants in baseline study.

    4. cancer (defined as cancer, recurrence of cancer and cancer metastasis) [3 year]

      The number of cancer outcomes will be collected. The incidence of cancer is calculated by dividing the number of cancer outcomes by the total number of participants in baseline study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All employees and retirees in Qingdao Port Group

    • Aged over 18 years old

    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • China National Center for Cardiovascular Diseases

    Investigators

    • Principal Investigator: Lixin Jiang, MD, PhD, Fuwai Hospital
    • Principal Investigator: Xiancheng Liu, MD, PhD, Qingdao Fuwai hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    China National Center for Cardiovascular Diseases
    ClinicalTrials.gov Identifier:
    NCT02329886
    Other Study ID Numbers:
    • 20141218
    First Posted:
    Jan 1, 2015
    Last Update Posted:
    Aug 11, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by China National Center for Cardiovascular Diseases
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 11, 2016