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NCT Number: NCT05435898

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Tenth People's Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200072, China

Location contact

Shikai Yu, MD, PhD

CONTACT

[email protected]

+86 18801790211

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. composite endpoint of cardiovascular events

    Time frame: 5 years

    rate of subject with myocardial infarction, stroke, heart failure, cardiovascular death

Secondary outcomes

  1. Individual cardiovascular events

    Time frame: 5 years

    rate of subject with individual components of composite endpoint

  2. all cause mortality

    Time frame: 5 years

    rate of death

  3. New on-set subclinical organ damage

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Jun 28, 2022
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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