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Cardiovascular Disease Cohort in Guangdong Province

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ClinicalTrials.gov Identifier: NCT03351907
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Min Xia, Sun Yat-sen University

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.

Condition or disease
Cardiovascular Disease

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study of Cardiovascular Disease in Guangdong Province
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2030



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Serum, Plasma, Urine and fecal samples for biochemical tests, biomarker examination and DNA extraction


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351907


Contacts
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Contact: Min Xia +86-2087332433 xiamin@mail.sysu.edu.cn
Contact: Min Xia +86-2087332433 1186510653@qq.com

Locations
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China, Guangdong
Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Min Xia, PhD    +86-2087332433    xiamin@mail.sysu.edu.cn   
Contact: Min Xia    +86-2087332433    1186510653@qq.com   
Sponsors and Collaborators
Min Xia
Investigators
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Principal Investigator: Min Xia School of Public Health,Nutrition and Food Hygiene,Sun Yat-sen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Min Xia, Professer, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03351907    
Other Study ID Numbers: 2017XXG1120
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases