Cardiovascular DiseasesNCT06387875
Cohort in Qianwan New District, Ningbo
An observational study of Cardiovascular Diseases and Stroke, run by RenJi Hospital at 1 site in China.
Trial summary
Our objective is to carry out research on prevention and control of noncommunicable chronic diseases, and establish a risk prediction mechanism for chronic diseases to promote early detection, early diagnosis and early treatment of chronic diseases in natural population in Qianwan District of Ningbo, significantly… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Stroke, Non-Communicable Chronic Diseases
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 30 Jun 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Relying on the manufacturing factories gathered around Hangzhou Bay Hospital, a relatively stable cohort of participants was provided. According to the entry criteria, eligible subjects were selected to be included in the Hangzhou Bay natural population cohort.
Who may be able to join
- 1) Local permanent residents aged 18 and above (including residents with household registration, or residents without household registration but with a permanent job);
- 2) No serious physical disability, can communicate normally;
- 3) Participate voluntarily and sign informed consent.
Who cannot join
- 1) Temporary resident and floating population;
- 2) There are serious health conditions unable to participate in the survey;
- 3) Those who are unwilling to accept the follow-up inspection of the project.
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
Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
Shanghai
Jun Pu, MD,PHD, 86-21-68383477, pujun310@hotmail.com
About this study
Official title: Prevention and Control of Chronic Noncommunicable Diseases in Natural Population in Qianwan New District, Ningbo
Our objective is to carry out research on prevention and control of noncommunicable chronic diseases, and establish a risk prediction mechanism for chronic diseases to promote early detection, early diagnosis and early treatment of chronic diseases in natural population in Qianwan District of Ningbo, significantly reduce medical costs and extend population life span.
Read the detailed description
- Through baseline survey (cross-sectional survey) and prospective cohort design, the health status information and biological samples of residents in Hangzhou Bay Hospital were collected, and the physical, psychological and social adaptability information was collected through questionnaires and other forms, basic tests and omics measurements were carried out based on the collected samples to build a multi-dimensional data platform.
- Develop a disease risk prediction model based on big data platform, conduct high-risk population screening and establish risk assessment files; In view of the common health problems in the study population, the key factors and effects of health status were analyzed comprehensively, and the corresponding mathematical model was established to form the prediction of health status. Finally to establish the stratified standard of population health status and provide effective health guidance. Questionnaire survey on epidemiology: The Hangzhou Bay Natural Population Cohort Questionnaire was designed according to the principles and requirements of cohort study. All respondents who entered the cohort will sign informed consent, receive face-to-face interview with uniformly trained investigators, and the questionnaire will be reviewed by quality control personnel for quality control. Physical examination: The examination contents include height, weight, blood pressure, waist circumference, hip circumference, hearing, vision, medical history and surgery, inbody composition, chest film, electrocardiogram, B-ultrasound, non-invasive arteriosclerosis examination, vascular endothelial ultrasound and other imaging examinations. Clinical biochemical test: 5-10 ml of blood, 20 ml of urine and 5 g of feces were collected (if necessary) according to the chronic non-communicable disease spectrum and clinical test requirements in Qianwan New District of Ningbo; The blood samples and urine were tested for biochemistry, liver and kidney function, blood lipids and electrolytes according to clinical testing requirements, as well as multi-omics indicators as needed.
- Prospective study data: Follow-up of the cohort population (disease occurrence, death, migration, etc.) was conducted through annual active follow-up (telephone, interview, etc.) and passive follow-up, including data of all-cause death, incidence of any kind of diseases.
- Keywords
- cohort, natural population, Non-communicable Chronic Disease
- Medical subject headings
- Cardiovascular Diseases, Stroke, Noncommunicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Mortality of all-cause disease were calculated by age, gender and area compared by different health management mode.
Measured: 4 years
incidence of cardio-cerebrovascular diseases
Incidence of Cardiovascular and Cerebrovascular diseases were calculated by age, gender and area compared by different health management mode.
Measured: 4 years
incidence of other non-communicable chronic diseases
Incidence of other non-communicable chronic diseases were calculated by age, gender and area compared by different health management mode.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Nov 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Hangzhou Bay Hospital
- Responsible party
- Sponsor
- Investigators
- Jun Pu, MD, PhD, Principal investigator, Ningbo Hangzhou Bay Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387875
- Sponsor's protocol ID
- Hangzhou Bay Cohort
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Control of Chronic Noncommunicable Diseases in Natural Population in Qianwan New District, Ningbo
- ClinicalTrials.gov ID
- NCT06387875
- Acronym / sponsor ID
- Hangzhou Bay Cohort
- Keywords
- cohort, natural population, Non-communicable Chronic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Ningbo Hangzhou Bay Hospital
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Apr 2024 (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.
Our objective is to carry out research on prevention and control of noncommunicable chronic diseases, and establish a risk prediction mechanism for chronic diseases to promote early detection, early diagnosis and early treatment of chronic diseases in natural population in Qianwan District of Ningbo, significantly reduce medical costs and extend population life span.
Detailed description
- Through baseline survey (cross-sectional survey) and prospective cohort design, the health status information and biological samples of residents in Hangzhou Bay Hospital were collected, and the physical, psychological and social adaptability information was collected through questionnaires and other forms, basic tests and omics measurements were carried out based on the collected samples to build a multi-dimensional data platform.
- Develop a disease risk prediction model based on big data platform, conduct high-risk population screening and establish risk assessment files; In view of the common health problems in the study population, the key factors and effects of health status were analyzed comprehensively, and the corresponding mathematical model was established to form the prediction of health status. Finally to establish the stratified standard of population health status and provide effective health guidance. Questionnaire survey on epidemiology: The Hangzhou Bay Natural Population Cohort Questionnaire was designed according to the principles and requirements of cohort study. All respondents who entered the cohort will sign informed consent, receive face-to-face interview with uniformly trained investigators, and the questionnaire will be reviewed by quality control personnel for quality control. Physical examination: The examination contents include height, weight, blood pressure, waist circumference, hip circumference, hearing, vision, medical history and surgery, inbody composition, chest film, electrocardiogram, B-ultrasound, non-invasive arteriosclerosis examination, vascular endothelial ultrasound and other imaging examinations. Clinical biochemical test: 5-10 ml of blood, 20 ml of urine and 5 g of feces were collected (if necessary) according to the chronic non-communicable disease spectrum and clinical test requirements in Qianwan New District of Ningbo; The blood samples and urine were tested for biochemistry, liver and kidney function, blood lipids and electrolytes according to clinical testing requirements, as well as multi-omics indicators as needed.
- Prospective study data: Follow-up of the cohort population (disease occurrence, death, migration, etc.) was conducted through annual active follow-up (telephone, interview, etc.) and passive follow-up, including data of all-cause death, incidence of any kind of diseases.
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
- Relying on the manufacturing factories gathered around Hangzhou Bay Hospital, a relatively stable cohort of participants was provided. According to the entry criteria, eligible subjects were selected to be included in the Hangzhou Bay natural population cohort.
Key inclusion criteria (3 listed)
- 1) Local permanent residents aged 18 and above (including residents with household registration, or residents without household registration but with a permanent job);
- 2) No serious physical disability, can communicate normally;
- 3) Participate voluntarily and sign informed consent.
Key exclusion criteria (3 listed)
- 1) Temporary resident and floating population;
- 2) There are serious health conditions unable to participate in the survey;
- 3) Those who are unwilling to accept the follow-up inspection of the project.
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
death
Time frame: 4 years
Mortality of all-cause disease were calculated by age, gender and area compared by different health management mode.
incidence of cardio-cerebrovascular diseases
Time frame: 4 years
Incidence of Cardiovascular and Cerebrovascular diseases were calculated by age, gender and area compared by different health management mode.
incidence of other non-communicable chronic diseases
Time frame: 4 years
Incidence of other non-communicable chronic diseases were calculated by age, gender and area compared by different health management mode.
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 29 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Jun Pu, MD, PhD principal investigator
Ningbo Hangzhou Bay Hospital
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 Cardiovascular Diseases and Stroke, run by RenJi 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 3 inclusion and 3 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 29 Apr 2024. 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 Jun Pu, MD, PhD (86-21-68383477, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 4 years). The study lists 3 primary outcomes in all. 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 29 Apr 2024.