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Completed

NCT Number: NCT02329886

The Qingdao Port Health Study

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.

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Key information

Conditions

Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All employees and retirees in Qingdao Port Group
  • Aged over 18 years old

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. all cause mortality

    Time frame: 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 outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 outcomes

  1. chronic obstructive pulmonary disease

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2015
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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