The Qingdao Port Health Study

Chronic Disease Clinical Trial

Official title:

The Qingdao Port Health Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329886
• Other study ID #: 20141218
• Status: Completed
• Phase: N/A
• First received: December 20, 2014
• Last updated: August 10, 2016
• Start date: March 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Center for Cardiovascular Diseases
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25000
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All employees and retirees in Qingdao Port Group

• Aged over 18 years old

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	chronic obstructive pulmonary disease	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.	3 year	No
Other	chronic renal insufficiency	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 year	No
Other	chronic liver diseases (defined as cirrhosis and hepatic failure)	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.	3 year	No
Other	cancer (defined as cancer, recurrence of cancer and cancer metastasis)	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.	3 year	No
Primary	all cause mortality	The number of all cause death will be collected. The effects of modified risk factors on all cause mortality will be assessed.	3 year	No
Secondary	Heart diseases (defined as myocardial infarction, agina requiring hospitalization and acute/chronic heart failure)	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.	3 year	No
Secondary	stroke (defined as ischemic stroke and hemorraghic stroke)	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 year	No
Secondary	revascularization (defined as percutaneous coronary intervention, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty)	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.	3 year	No