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Assessment and Digital-health Based Intervention on Subclinical Organ Damage and Cardiovascular Risk in Chinese

Comprehensive Assessment and Digital-health Based Intervention on Early-stage Cardiovascular Organ Damage and Cardiovascular Risk in Chinese: An All-comer Registry Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05435898
Enrollment
4000
Registered
2022-06-28
Start date
2022-10-01
Completion date
2029-09-30
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cardiovascular Morbidity, Digital Health, Subclinical Organ Damage

Keywords

Coronary Heart Disease, Arterial stiffness, Left ventricular hypertrophy, Left ventricular diastolic dysfunction, Intima-media thickness, Cardiovascular events

Brief summary

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.

Detailed description

In this project, we will register outpatients with cardiovascular diseases and healthy subjects for cardiovascular health check-up in the cardiovascular research clinic of our hospital, comprehensively evaluate their cardiovascular risk factors, subclinical organ damage and cardiovascular diseases at baseline. For participants who is willing to go further, a digital-based intervention will be provided for them to improve their knowledge and behaviour on cardiovascular health. For all participants, their status on subclinical organ damage, cardiovascular diseases and events will be followed within five years. The primary outcome is the composite endpoints of cardiovascular adverse events including acute coronary syndrome, myocardial infarction, heart failure, cardiovascular death. The secondary outcomes include individual cardiovascular adverse events, all-cause mortality, subclinical organ damage including cardiac damage (left ventricular hypertrophy and diastolic dysfunction), renal damage (chronic kidney disease, microalbuminuria), and vascular damage (arterial stiffness, plaques, intima-median thickening, retina arteriosclerosis). By doing these, we will be able to build a registry study and to reveal the epidemiology of subclinical organ damage, validate the association between subclinical organ damage and cardiovascular events in Chinese, and explore the significance of digital-based intervention in the prevention from subclinical organ damage and cardiovascular diseases and events.

Interventions

None listed

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
composite endpoint of cardiovascular events5 yearsrate of subject with myocardial infarction, stroke, heart failure, cardiovascular death

Secondary

MeasureTime frameDescription
Individual cardiovascular events5 yearsrate of subject with individual components of composite endpoint
all cause mortality5 yearsrate of death
New on-set subclinical organ damage5 yearsRate 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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026