Shanghai Community Cohort Establishment and Follow-up

July 8, 2023 updated by: Jun Pu, RenJi Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Eligible residents from second-class medical units and community health service centers with mature conditions.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 years
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.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Normalized management rate of Cardiovascular and Cerebrovascular disease
Time Frame: 5 years
Normalized management rate of Cardiovascular and Cerebrovascular disease were calculated by different management mode.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jun Pu, MD,PhD, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shanghai Community Cohort

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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