Reduction of Risk for Cardiovascular Diseases

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431400
• Other study ID #: NFEC-2021-083
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jiancheng Xiu, MD
• Phone: +86-020-61648319
• Email: xiujch[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
China	The Fourth People's Hospital of Foshan	Foshan	Guangdong
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

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