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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Cardiovascular Morbidity; Digital Health; Subclinical Organ Damage

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 Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Shanghai Tenth People's Hospital, Tongji University School of Medicine
      • Contact: Shikai Yu, MD, PhD; Phone Number: +86 18801790211; Email: shikaiyu@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite endpoint of cardiovascular events	rate of subject with myocardial infarction, stroke, heart failure, cardiovascular death	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual cardiovascular events	rate of subject with individual components of composite endpoint	5 years
all cause mortality	rate of death	5 years
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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Yi Zhang, PhD, MD, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): September 30, 2029
• Study Completion (Anticipated): September 30, 2029

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Arterial stiffness; Coronary Heart Disease; Cardiovascular events; Left ventricular hypertrophy; Intima-media thickness; Left ventricular diastolic dysfunction
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: NSS_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No