Clinical trial NCT05431400: Reduction of Risk for Cardiovascular Diseases
Official title: Reducing the Risk of Cardiovascular Diseases in Community-dwelling Adults: an Ambispective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular Diseases
Prediction model
Community
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 5 years
Secondary outcomes:
measure: Atherosclerotic cardiovascular events
timeFrame: 5 years
measure: All-cause mortality
timeFrame: 5 years
measure: Cognitive dysfunction
timeFrame: 5 years
measure: Renal functional deterioration
timeFrame: 5 years
measure: Renal replacement therapy and/or death due to acute renal failure
timeFrame: 5 years
measure: Incident atrial fibrillation
timeFrame: 5 years
Other outcomes:
Locations:
city: Foshan
country: China
facility: The Fourth People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jiancheng Xiu, MD
role: PRINCIPAL_INVESTIGATOR
References: