The Qingdao Port Health Study

August 10, 2016 updated by: China National Center for Cardiovascular Diseases
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

25000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Employees and retirees in Qingdao Port Group, Shandong province, China

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 year
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 year
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.
3 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 year
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 year
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.
3 year
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.
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

December 20, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (Estimate)

January 1, 2015

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20141218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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