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The Qingdao Port Health Study

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ClinicalTrials.gov Identifier: NCT02329886
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Chronic Disease

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.

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Study Type : Observational
Actual Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Qingdao Port Health Study
Study Start Date : March 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples With DNA
In 2013, whole blood samples were collected for future genetic studies. And saliva and urine samples were also collected for future analysis.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Employees and retirees in Qingdao Port Group, Shandong province, China
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329886


Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
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Principal Investigator: Lixin Jiang, MD, PhD Fuwai Hospital
Principal Investigator: Xiancheng Liu, MD, PhD Qingdao Fuwai hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT02329886    
Other Study ID Numbers: 20141218
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: January 2016
Keywords provided by China National Center for Cardiovascular Diseases:
chronic diseases
risk factors
health outcomes
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes