Clinical trial NCT02329886: The Qingdao Port Health Study
Official title: The Qingdao Port Health Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Keywords: chronic diseases
risk factors
health outcomes
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2015-01-01
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employees and retirees in Qingdao Port Group, Shandong province, China

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: all cause mortality
timeFrame: 3 year
Secondary outcomes:
measure: Heart diseases (defined as myocardial infarction, agina requiring hospitalization and acute/chronic heart failure)
timeFrame: 3 year
measure: stroke (defined as ischemic stroke and hemorraghic stroke)
timeFrame: 3 year
measure: revascularization (defined as percutaneous coronary intervention, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty)
timeFrame: 3 year
Other outcomes:
measure: chronic obstructive pulmonary disease
timeFrame: 3 year
measure: chronic renal insufficiency
timeFrame: 3 year
measure: chronic liver diseases (defined as cirrhosis and hepatic failure)
timeFrame: 3 year
measure: cancer (defined as cancer, recurrence of cancer and cancer metastasis)
timeFrame: 3 year
Locations:
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Lixin Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Qingdao Fuwai hospital
name: Xiancheng Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spatz ES, Jiang X, Lu J, Masoudi FA, Spertus JA, Wang Y, Li X, Downing NS, Nasir K, Du X, Li J, Krumholz HM, Liu X, Jiang L. Qingdao Port Cardiovascular Health Study: a prospective cohort study. BMJ Open. 2015 Dec 9;5(12):e008403. doi: 10.1136/bmjopen-2015-008403.