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Clinical Trial Summary

Our objective is to establish a natural population-based 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05206643
Study type Observational
Source RenJi Hospital
Contact Jun Pu, MD,PhD
Phone 86-21-68383477
Email [email protected]
Status Recruiting
Phase
Start date August 7, 2019
Completion date December 31, 2025

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