Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04517513 |
| Other study ID # |
Shanghai Community Cohort |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 7, 2019 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
July 2023 |
| Source |
RenJi Hospital |
| Contact |
Jun Pu, MD,PhD |
| Phone |
86-21-68383477 |
| Email |
pujun310[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
