NCT05431400

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

6 years

First QC Date

June 5, 2022

Last Update Submit

June 23, 2022

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular DiseasesPrediction modelCommunity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Atherosclerotic cardiovascular events

    5 years

  • All-cause mortality

    5 years

  • Cognitive dysfunction

    5 years

  • Renal functional deterioration

    5 years

  • Renal replacement therapy and/or death due to acute renal failure

    5 years

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Refuse to provide informed consent;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Fourth People's Hospital of Foshan

Foshan, Guangdong, 528041, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

For the prospective part, serum, plasma, urine and fecal samples will be collected for biochemical tests, biomarker examination and DNA extraction.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jiancheng Xiu, MD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiancheng Xiu, MD

CONTACT

+86-020-61648319xiujch@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2022

First Posted

June 24, 2022

Study Start

January 1, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 24, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)