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

Not yet recruiting

• Conditions: Cardiovascular Morbidity; Cardiovascular Diseases; Subclinical Organ Damage; Digital Health

• Registration Number: NCT05435898
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-23
• Last Update Submitted: 2022-06-23
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28
• Study Start: 2022-10-01
• Primary Completion: 2029-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite endpoint of cardiovascular events	5 years	rate of subject with myocardial infarction, stroke, heart failure, cardiovascular death

Secondary Outcome Measures

Name	Time	Method
Individual cardiovascular events	5 years	rate of subject with individual components of composite endpoint
all cause mortality	5 years	rate of death
New on-set subclinical organ damage	5 years	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).

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, Shanghai, China