The Qingdao Port Health Study

Completed

• Conditions: Chronic Disease

• Registration Number: NCT02329886
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-12-20
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2015-01-01
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.