Chronic DiseaseNCT02329886
The Qingdao Port Health Study
An observational study of Chronic Disease, run by China National Center for Cardiovascular Diseases.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- How many people
- 25,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Employees and retirees in Qingdao Port Group, Shandong province, China
Who may be able to join
- All employees and retirees in Qingdao Port Group
- Aged over 18 years old
Who cannot join
- -
About this study
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.
Read the 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.
- Conditions
- Chronic Disease
- Keywords
- chronic diseases, risk factors, health outcomes
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 year
Secondary outcomes (3)
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.
Measured: 3 year
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.
Measured: 3 year
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.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startMar 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lixin Jiang, MD, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai HospitalXiancheng Liu, MD, PhD, Principal investigator, Qingdao Fuwai hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329886
- Sponsor's protocol ID
- 20141218
- Status last verified
- Jan 2016
- First submitted
- 20 Dec 2014
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26656011
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Qingdao Port Health Study
- ClinicalTrials.gov ID
- NCT02329886
- Acronym / sponsor ID
- 20141218
- Conditions
- Chronic Disease
- Keywords
- chronic diseases, risk factors, health outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,000 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Mar 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Employees and retirees in Qingdao Port Group, Shandong province, China
Key inclusion criteria (2 listed)
- All employees and retirees in Qingdao Port Group
- Aged over 18 years old
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
Heart diseases (defined as myocardial infarction, agina requiring hospitalization and acute/chronic heart failure)
Time frame: 3 year
stroke (defined as ischemic stroke and hemorraghic stroke)
Time frame: 3 year
revascularization (defined as percutaneous coronary intervention, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty)
Time frame: 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Derived from this study: PubMed 26656011Spatz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lixin Jiang, MD, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Xiancheng Liu, MD, PhD principal investigator
Qingdao Fuwai hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by China National Center for Cardiovascular Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.