Reduction of Risk for Cardiovascular Diseases

Recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT05431400
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

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 Timeline

• Study Start: 2020-01-01
• Status Verified: 2022-06
• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-23
• Last Update Submitted: 2022-06-23
• Study First Posted: 2022-06-24
• Last Update Posted: 2022-06-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	5 years	Major adverse cardiovascular events include all-cause mortality, acute myocardial infarction, coronary heart disease, heart failure and stroke.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

The Fourth People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China