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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05435898
• Other study ID #: NSS_2
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: September 30, 2029

Study information

• Verified date: June 2022
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2029
• 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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital, Tongji University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

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