- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03351907
Cardiovascular Disease Cohort in Guangdong Province
May 3, 2022 updated by: Min Xia
Prospective Cohort Study of Cardiovascular Disease in Guangdong Province
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
5,000 patients (30-85 years old) with primary hypertension, coronary heart disease, heart failure or peripheral vascular disease and who have been living in Guangdong province for more than 5 years will be recruited.
All participants will be prospectively followed up for the incidence of all-cause and cardiovascular mortality.
Information about socio-demographic, diet, lifestyle, psychological status, medical history and current medication will be collected by questionnaires.
Physical examinations including height, weight, waist and hip circumferences, blood pressure, fat mass and vital capacity will be conducted.Besides, blood, urine and fecal samples will be collected for further analysis.
The associations between diet and lifestyle and risks for cardiovascular disease will be evaluated.
Study Type
Observational
Enrollment (Anticipated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510080
- Sun Yat-sen University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cardiovascular disease patients (30-85 years old) who have been living in Guangdong province for more than 5 years.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-Cause Mortality
Time Frame: 4 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular Mortality
Time Frame: 4 years
|
Cardiovascular mortality was defned as death attributable to an ischemic cardiovascular cause (including fatal MI, stroke, and peripheral arterial disease) or sudden death due to an unknown but presumed cardiovascular cause in high-risk patients.
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2017
Primary Completion (ANTICIPATED)
December 31, 2030
Study Completion (ANTICIPATED)
December 31, 2030
Study Registration Dates
First Submitted
November 20, 2017
First Submitted That Met QC Criteria
November 20, 2017
First Posted (ACTUAL)
November 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 5, 2022
Last Update Submitted That Met QC Criteria
May 3, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017XXG1120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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