Cardiovascular DiseasesNCT04517513
Shanghai Community Cohort Establishment and Follow-up
An observational study of Cardiovascular Diseases, run by RenJi Hospital at 1 site in China.
Trial summary
Our objective is to establish a natural population cohort in East China based on the latest scientific researches, preliminary findings of the project team, and a close cooperation model of the Specialist Medical Consortium. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 80,000 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2019to 31 Dec 2025
- 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 35 years and older
- All sexes
- Adult, Older adult
Study population: Eligible residents from second-class medical units and community health service centers with mature conditions.
Who may be able to join
- Patients >= 35y
- Registered Permanent residents or have lived for more than 5 years and have local social security medical insurance
- Patients with no serious physical disability and can communicate normally
- Patients who participate voluntarily and sign informed consent
- Patients whose diseases and deaths are managed by the local health department
Who cannot join
- Temporary residents and floating population
- Patients with serious health conditions and cannot participate in the investigation
- Patients who are unwilling to accept follow-up inspections of the project
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200000
Song ding, MD, 86-21-68383477, dingsong1105@163.com
About this study
Our objective is to establish a natural population cohort in East China based on the latest scientific researches, preliminary findings of the project team, and a close cooperation model of the Specialist Medical Consortium.
Firstly, we will focus on the information and management status of high-risk, single-patient, and co-occurring patient groups of cardio cerebral diseases such as coronary heart disease and stroke. We plan to integrate the questionnaire data and sample database information into the cardio-cerebral "co-prevention and management" information platform, in order to establish a cardiovascular and cerebrovascular disease management system.
Secondly, we aim to develop a new risk prediction model for heart and brain diseases based on the big data platform, lead the establishment of the "co-prevention and management" innovation management model for cardio cerebral diseases, and explore an integrated and innovative health management model for the prevention and treatment of cardio cerebral diseases for China.
Read the detailed description
The research is based on a combination of retrospective, cross-sectional, and prospective cohort studies.
In particular, the retrospective cohort study collects historical information of the studied cohort from 2014 to 2018 from secondary medical units, residents' community health service centers, emergency departments, and their health records. Patients' past diseases such as hypertension, diabetes, cardiovascular and cerebrovascular diseases, information on the history of drug use, and lifestyle (if any) are collected and sorted out. Moreover, information on cardiovascular and cerebrovascular morbidity and death among members of the cohort is collected.
The cross-sectional study builds on the baseline research conducts during 2019-2020. Specifically, baseline research contains the following procedures:
- Epidemiological survey: Design the Cardio-Cerebrovascular Disease Prevention and Control Questionnaire in accordance with the principles and requirements of the cohort study. On the premise of informed notification, data are collected through face-to-face interviews between the studied cohort and investigators who signed the informed consent and received uniform training. Quality control staff will review the questionnaire for quality control. The main content includes demographic sociology, lifestyle, physical exercise, daily eating habits, usage of dietary supplements, personal and family medical history, psychological assessment, and female fertility history.
- Physical examination: the examination is performed by the clinical professional physician in the health service center. The examination content includes height, weight, blood pressure, hearing, vision, internal surgery, body fat composition (optional), chest radiograph, electrocardiogram, B-ultrasound, carotid ultrasound (optional), and other imaging examinations.
- Clinical biochemical test: fasting blood collection should be performed by all individuals upon their enrollment. The blood samples collected are tested for biochemistry, liver and kidney function, blood lipid analysis, and electrolyte analysis in accordance with clinical testing requirements.
- Biological specimen collection: collect 10ml ethylenediaminetetraacetic acid blood samples using a health checkup, then send them to renji sample bank for separation within 2 hours, and store in -80℃ ultra-low temperature refrigerator.
Lastly, the prospective study will be conducted from 2020 to 2025. Through annual active (phone, face-to-face interview, etc.) and passive follow-ups, we track the health status of the cohort including cardio-cerebral vascular disease occurrence, death, migration, etc., collect data that matches its baseline value, analyze the morbidity and mortality of the cohort population, and grasp the morbidity, the order of the diseases, mortality, and order of the cause of death for each disease, especially the cardiovascular and cerebrovascular diseases.
- Conditions
- Cardiovascular Diseases
- Keywords
- Cohort Study, Natural Population, China
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular and Cerebrovascular incidence
Incidence of Cardiovascular and Cerebrovascular disease were calculated by age, gender and area compared by different health management mode.
Measured: 5 years
Cardiovascular and Cerebrovascular mortality
Mortality of Cardiovascular and Cerebrovascular disease were calculated by age, gender and area compared by different health management mode.
Measured: 5 years
Secondary outcomes (1)
Normalized management rate of Cardiovascular and Cerebrovascular disease
Normalized management rate of Cardiovascular and Cerebrovascular disease were calculated by different management mode.
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 posted18 Aug 2020
- Study start7 Aug 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Other
- Enrolment
- 80,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jinqiao Community Health Service Center of Pudong new area, Shanghai, Heqing Community Health Service Center of Pudong new area, Shanghai, Weifang Community Health Service Center of Pudong new area, Shanghai, Jinyang Community Health Service Center of Pudong new area, Shanghai
- Responsible party
- Principal investigator, Jun Pu, RenJi Hospital
- Investigators
- Jun Pu, MD,PhD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517513
- Sponsor's protocol ID
- Shanghai Community Cohort
- Status last verified
- Jul 2023
- First submitted
- 16 Aug 2020
- Last updated
- 11 Jul 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Community Cohort Establishment and Follow-up
- ClinicalTrials.gov ID
- NCT04517513
- Acronym / sponsor ID
- Shanghai Community Cohort
- Conditions
- Cardiovascular Diseases
- Keywords
- Cohort Study, Natural Population, China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Jinqiao Community Health Service Center of Pudong new area, Shanghai, Heqing Community Health Service Center of Pudong new area, Shanghai, Weifang Community Health Service Center of Pudong new area, Shanghai, Jinyang Community Health Service Center of Pudong new area, Shanghai
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Aug 2020 (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 establish a natural population cohort in East China based on the latest scientific researches, preliminary findings of the project team, and a close cooperation model of the Specialist Medical Consortium.
Firstly, we will focus on the information and management status of high-risk, single-patient, and co-occurring patient groups of cardio cerebral diseases such as coronary heart disease and stroke. We plan to integrate the questionnaire data and sample database information into the cardio-cerebral "co-prevention and management" information platform, in order to establish a cardiovascular and cerebrovascular disease management system.
Secondly, we aim to develop a new risk prediction model for heart and brain diseases based on the big data platform, lead the establishment of the "co-prevention and management" innovation management model for cardio cerebral diseases, and explore an integrated and innovative health management model for the prevention and treatment of cardio cerebral diseases for China.
Detailed description
The research is based on a combination of retrospective, cross-sectional, and prospective cohort studies.
In particular, the retrospective cohort study collects historical information of the studied cohort from 2014 to 2018 from secondary medical units, residents' community health service centers, emergency departments, and their health records. Patients' past diseases such as hypertension, diabetes, cardiovascular and cerebrovascular diseases, information on the history of drug use, and lifestyle (if any) are collected and sorted out. Moreover, information on cardiovascular and cerebrovascular morbidity and death among members of the cohort is collected.
The cross-sectional study builds on the baseline research conducts during 2019-2020. Specifically, baseline research contains the following procedures:
- Epidemiological survey: Design the Cardio-Cerebrovascular Disease Prevention and Control Questionnaire in accordance with the principles and requirements of the cohort study. On the premise of informed notification, data are collected through face-to-face interviews between the studied cohort and investigators who signed the informed consent and received uniform training. Quality control staff will review the questionnaire for quality control. The main content includes demographic sociology, lifestyle, physical exercise, daily eating habits, usage of dietary supplements, personal and family medical history, psychological assessment, and female fertility history.
- Physical examination: the examination is performed by the clinical professional physician in the health service center. The examination content includes height, weight, blood pressure, hearing, vision, internal surgery, body fat composition (optional), chest radiograph, electrocardiogram, B-ultrasound, carotid ultrasound (optional), and other imaging examinations.
- Clinical biochemical test: fasting blood collection should be performed by all individuals upon their enrollment. The blood samples collected are tested for biochemistry, liver and kidney function, blood lipid analysis, and electrolyte analysis in accordance with clinical testing requirements.
- Biological specimen collection: collect 10ml ethylenediaminetetraacetic acid blood samples using a health checkup, then send them to renji sample bank for separation within 2 hours, and store in -80℃ ultra-low temperature refrigerator.
Lastly, the prospective study will be conducted from 2020 to 2025. Through annual active (phone, face-to-face interview, etc.) and passive follow-ups, we track the health status of the cohort including cardio-cerebral vascular disease occurrence, death, migration, etc., collect data that matches its baseline value, analyze the morbidity and mortality of the cohort population, and grasp the morbidity, the order of the diseases, mortality, and order of the cause of death for each disease, especially the cardiovascular and cerebrovascular diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible residents from second-class medical units and community health service centers with mature conditions.
Key inclusion criteria (5 listed)
- Patients >= 35y
- Registered Permanent residents or have lived for more than 5 years and have local social security medical insurance
- Patients with no serious physical disability and can communicate normally
- Patients who participate voluntarily and sign informed consent
- Patients whose diseases and deaths are managed by the local health department
Key exclusion criteria (3 listed)
- Temporary residents and floating population
- Patients with serious health conditions and cannot participate in the investigation
- Patients who are unwilling to accept follow-up inspections 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
Cardiovascular and Cerebrovascular incidence
Time frame: 5 years
Incidence of Cardiovascular and Cerebrovascular disease were calculated by age, gender and area compared by different health management mode.
Cardiovascular and Cerebrovascular mortality
Time frame: 5 years
Mortality of Cardiovascular and Cerebrovascular disease were calculated by age, gender and area compared by different health management mode.
1 secondary outcome
Normalized management rate of Cardiovascular and Cerebrovascular disease
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 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. This study is not recruiting at the moment.
Jun Pu, MD,PhD principal investigator
RenJi 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, 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 5 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: status not confirmed, as of the sponsor's last update on 11 Jul 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?
Results are not available in the source record.
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?
Cardiovascular and Cerebrovascular incidence (time frame: 5 years). The study lists 2 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 11 Jul 2023.