Reduction of Risk for Cardiovascular Diseases

Reducing the Risk of Cardiovascular Diseases in Community-dwelling Adults: an Ambispective Cohort Study

To establish and evaluate a new prediction model for assessing cardiovascular disease risk in community-dwelling adults.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases

Detailed Description

This is an ambispective, observational cohort study. In the retrospective part, we will enroll residents from Guangzhou or Foshan who participated in the annual health checks provided by the Chinese National Basic Public Health Service project between January 2015 and December 2019. The demographic characteristics, anthropometric measurements, laboratory assays, medical history, living habits, and medications will be collected through personal electronic health records obtained from the regional chronic disease management platform. In the prospective part, residents who participated in the annual health checks provided by the Chinese National Basic Public Health Service project after January 2020 will be enrolled. In addition to the data collected in the retrospective part, blood, urine and fecal samples and lifestyle questionnaires will be collected for further analysis. All participants will be followed-up till December 2025. A new prediction model for assessing cardiovascular disease risk will be established and evaluated.

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528041
      • Recruiting
      • The Fourth People's Hospital of Foshan
      • Contact: Guifang Hu, MD; Phone Number: +86-020-61648653; Email: guif_hu@sina.com
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Jiancheng Xiu, MD; Phone Number: 41049 86-020-61648165; Email: xiujch@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling adults in Guangzhou or Foshan who participated in the annual health checks provided by the Chinese National Basic Public Health Service project.

To participate in the Chinese National Basic Public Health Service project, one must meet at least one of the following conditions: 1. Age ≥ 65 years; 2. Diabetes mellitus; 3. Hypertension.

Description

Inclusion Criteria:

• Meet at least one of the following conditions: 1. Age ≥ 65 years; 2. Diabetes mellitus; 3. Hypertension;

Exclusion Criteria:

• Refuse to provide informed consent;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events	Major adverse cardiovascular events include all-cause mortality, acute myocardial infarction, coronary heart disease, heart failure and stroke.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atherosclerotic cardiovascular events	Atherosclerotic cardiovascular events include acute myocardial infarction, coronary heart disease, heart failure and fatal and non-fatal stroke.	5 years
All-cause mortality	Defined as any death after enrollment.	5 years
Cognitive dysfunction	Defined as Montreal Cognitive Assessment (MoCA) Score < 26 points.	5 years
Renal functional deterioration	Evaluated through change in estimated glomerular filtration rate.	5 years
Renal replacement therapy and/or death due to acute renal failure		5 years
Incident atrial fibrillation	Atrial fibrillation is diagnosed according to the 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation.	5 years

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2025
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (ACTUAL): June 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Community; Prediction model
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: NFEC-2021-083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No