Chronic DiseaseNCT06102187
Cohort Study in Fujian Province
An observational study of Chronic Disease, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
In this study, Chinese residents aged 35 to 75 years old were recruited from Fujian Province. Physical examination, questionnaire survey and biological sample collection were performed at baseline, and at least 4 years of follow-up were conducted. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- How many people
- 150,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 150,000 adult China aged 35 to 74 who have lived in urban or rural areas of Fuzhou, Putian, Quanzhou, Nanping, Xiamen, Zhangzhou, Longyan, Sanming and Ningde in Fujian Province for more than 6 months without cardiovascular disease history and major disability.
Who may be able to join
- Aged 35-75, having lived in Fuzhou, Putian, Quanzhou, Nanping, Xiamen, Zhangzhou, Longyan, Sanming, or Ningde in Fujian Province for more than 6 months.
Who cannot join
- Anyone diagnosed with coronary heart disease, stroke, or cancer.
- Anyone with a severe disability who is unable to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350000
Kaiyang Lin, Doctor, 86-0591-88217410, lky004@hotmail.com
About this study
Official title: Fujian Cohort Study of cARdiomEtabolic Disease and Comorbidity(Fu-CARE)
In this study, Chinese residents aged 35 to 75 years old were recruited from Fujian Province. Physical examination, questionnaire survey and biological sample collection were performed at baseline, and at least 4 years of follow-up were conducted. Information on newly discovered cardiovascular metabolic illnesses and comorbidities was collected during follow-up, and repeated surveys similar to baseline were conducted. To explore the relationship between environment, diet and lifestyle and the risk of cardiovascular metabolic diseases and concomitant disorders.
- Conditions
- Chronic Disease
- Keywords
- Cardiovascular and metabolic disease comorbidity
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Disease
It is a form of myocardial ischemia (insufficient blood supply to the heart muscle) caused by a decreased capacity of the coronary vessels. At the follow-up, the outcomes of coronary events were acquired. Coronary CTA examination and coronary angiography were the primary measuring modalities.
Measured: 5 years
Secondary outcomes (1)
other metabolic diseases
Including hypertension, stroke, diabetes, impaired glucose tolerance, obesity, cancer, chronic obstructive pulmonary disease and chronic kidney disease. These disorders were diagnosed using international standards, and the necessary information was gathered during face-to-face follow-up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- 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
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Disease Control and Prevention, Fujian, China National Center for Cardiovascular Diseases
- Responsible party
- Principal investigator, Kaiyang Lin, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102187
- Sponsor's protocol ID
- LYu
- Status last verified
- Nov 2023
- First submitted
- 22 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fujian Cohort Study of cARdiomEtabolic Disease and Comorbidity(Fu-CARE)
- ClinicalTrials.gov ID
- NCT06102187
- Acronym / sponsor ID
- LYu
- Conditions
- Chronic Disease
- Keywords
- Cardiovascular and metabolic disease comorbidity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Collaborators
- Center for Disease Control and Prevention, Fujian, China National Center for Cardiovascular Diseases
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2023 (actual)
- 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.
In this study, Chinese residents aged 35 to 75 years old were recruited from Fujian Province. Physical examination, questionnaire survey and biological sample collection were performed at baseline, and at least 4 years of follow-up were conducted. Information on newly discovered cardiovascular metabolic illnesses and comorbidities was collected during follow-up, and repeated surveys similar to baseline were conducted. To explore the relationship between environment, diet and lifestyle and the risk of cardiovascular metabolic diseases and concomitant disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 150,000 adult China aged 35 to 74 who have lived in urban or rural areas of Fuzhou, Putian, Quanzhou, Nanping, Xiamen, Zhangzhou, Longyan, Sanming and Ningde in Fujian Province for more than 6 months without cardiovascular disease history and major disability.
Key inclusion criteria (1 listed)
- Aged 35-75, having lived in Fuzhou, Putian, Quanzhou, Nanping, Xiamen, Zhangzhou, Longyan, Sanming, or Ningde in Fujian Province for more than 6 months.
Key exclusion criteria (2 listed)
- Anyone diagnosed with coronary heart disease, stroke, or cancer.
- Anyone with a severe disability who is unable to participate in the study.
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
Coronary Disease
Time frame: 5 years
It is a form of myocardial ischemia (insufficient blood supply to the heart muscle) caused by a decreased capacity of the coronary vessels. At the follow-up, the outcomes of coronary events were acquired. Coronary CTA examination and coronary angiography were the primary measuring modalities.
1 secondary outcome
other metabolic diseases
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Fujian Provincial Hospital at 1 site in China.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaiyang Lin (+8613559355708, lky7411@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Disease (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2023.