NCT03351907

Brief Summary

Patients with cardiovascular diseases from Guangdong province will be recruited and followed up for at least 4 years to evaluate the risk factors for cardiovascular-related mortality and disability. Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of all-cause and cardiovascular mortality will be investigated during follow-up.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress65%
Nov 2017Dec 2030

Study Start

First participant enrolled

November 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

13.2 years

First QC Date

November 20, 2017

Last Update Submit

May 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-Cause Mortality

    All-cause mortality was confrmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Guangdong Provincial Center for Disease Control and Prevention.

    4 years

Secondary Outcomes (1)

  • Cardiovascular Mortality

    4 years

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiovascular disease patients (30-85 years old) who have been living in Guangdong province for more than 5 years.

You may qualify if:

  • Cardiovascular disease patients (30-85 years old) who have been living in Guangdong province for more than 5 years.
  • Patients have been diagnosed with primary hypertension, coronary heart disease, heart failure or peripheral vascular disease, etc.

You may not qualify if:

  • Patients with cardiogenic (acute pericarditis, rheumatic coronary arteritis, hypertrophic cardiomyopathy, etc.) Or non-cardiogenic chest pain.
  • any subject who suffer from malignant tumors, infectious diseases, advanced liver disease, major disability and cannot participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • Li X, Lin Y, Wang S, Zhou S, Ju J, Wang X, Chen Y, Xia M. Extracellular Superoxide Dismutase Is Associated With Left Ventricular Geometry and Heart Failure in Patients With Cardiovascular Disease. J Am Heart Assoc. 2020 Aug 4;9(15):e016862. doi: 10.1161/JAHA.120.016862. Epub 2020 Jul 29.

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, Urine and fecal samples for biochemical tests, biomarker examination and DNA extraction

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Min Xia

    School of Public Health,Nutrition and Food Hygiene,Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professer

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 24, 2017

Study Start

November 1, 2017

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations