NCT04517513

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

6.4 years

First QC Date

August 16, 2020

Last Update Submit

July 8, 2023

Conditions

Keywords

Cohort StudyNatural PopulationChina

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular and Cerebrovascular incidence

    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

    Mortality of Cardiovascular and Cerebrovascular disease were calculated by age, gender and area compared by different health management mode.

    5 years

Secondary Outcomes (1)

  • Normalized management rate of Cardiovascular and Cerebrovascular disease

    5 years

Eligibility Criteria

Age35 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jun Pu, MD,PhD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiovascular Medicine

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 18, 2020

Study Start

August 7, 2019

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations