Cardiovascular Diseases Clinical Trial
Official title:
Comprehensive Assessment and Digital-health Based Intervention on Early-stage Cardiovascular Organ Damage and Cardiovascular Risk in Chinese: An All-comer Registry Study
Verified date | June 2022 |
Source | Shanghai 10th People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To comprehensively evaluate subclinical organ damage of Chinese adults and its association with future cardiovascular disease and events. To observe the significance of intervention based on digital health in preventing the onset and/or progression of subclinical organ damage and cardiovascular disease and events.
Status | Not yet recruiting |
Enrollment | 4000 |
Est. completion date | September 30, 2029 |
Est. primary completion date | September 30, 2029 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - aged 18 years or older - willing to participate the study and sign informed consent - available for long-term follow-up Exclusion Criteria: - severe heart disease (NYHA IV) - stage 4 or 5 CKD - malignant tumors or with life expectancy less than 5 years - stroke within 3 months - refuse to participate the study or not available for long-term follow up |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Tenth People's Hospital, Tongji University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai 10th People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | composite endpoint of cardiovascular events | rate of subject with myocardial infarction, stroke, heart failure, cardiovascular death | 5 years | |
Secondary | Individual cardiovascular events | rate of subject with individual components of composite endpoint | 5 years | |
Secondary | all cause mortality | rate of death | 5 years | |
Secondary | New on-set subclinical organ damage | Rate of subject with new on-set subclinical organ damage. Subclinical organ damage evaluated contains heart (left ventricular hypertrophy and diastolic dysfunction), kidneys (chronic kidney disease, microalbuminuria), vasculature (arterial stiffness, carotid plaque, intima-media thickness), and eye background (arteriosclerotic retinopathy). | 5 years |
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