Clinical trial NCT05435898: Assessment and Digital-health Based Intervention on Subclinical Organ Damage and Cardiovascular Risk in Chinese
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Diseases
Cardiovascular Morbidity
Subclinical Organ Damage
Digital Health
Keywords: Coronary Heart Disease
Arterial stiffness
Left ventricular hypertrophy
Left ventricular diastolic dysfunction
Intima-media thickness
Cardiovascular events
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All healthy subjects having cardiovascular health check-up and patients with cardiovascular diseases in the cardiovascular research clinic of our hospital are eligible for this study

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.

Eligibility criteria: 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

Primary outcomes:
measure: composite endpoint of cardiovascular events
timeFrame: 5 years
Secondary outcomes:
measure: Individual cardiovascular events
timeFrame: 5 years
measure: all cause mortality
timeFrame: 5 years
measure: New on-set subclinical organ damage
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital, Tongji University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yi Zhang, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: