Assessment and Digital-health Based Intervention on Subclinical Organ Damage and Cardiovascular Risk in Chinese
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Cardiovascular Morbidity, Subclinical Organ Damage, Digital Health. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- composite endpoint of cardiovascular events [Time frame: 5 years]
Secondary outcome measures (3)
- Individual cardiovascular events [Time frame: 5 years]
- all cause mortality [Time frame: 5 years]
- New on-set subclinical organ damage [Time frame: 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Tenth People's Hospital, Tongji University School of Medicine — Shanghai
Publications
- Wang B, Gao Y, Zhao Y, Jia P, Han J, Li H, Zhang Y, Xu Y. Prognostic Value of Angiography-Derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease Undergoing Rotational Atherectomy. Rev Cardiovasc Med. 2023 Apr 27;24(5):131. doi: 10.31083/j.rcm2405131. eCollection 2023 May. PMID 39076748
- Hou J, Li M, Han J, Yu S, Jia X, Sun F, Zhang Y. Northern Shanghai Study II: systematic assessment and management of early organ damage and its role in preventing and reducing cardiovascular risk-protocol of a prospective study. BMJ Open. 2023 Dec 30;13(12):e073423. doi: 10.1136/bmjopen-2023-073423. PMID 38159946
- Wang B, Gao Y, Zhao Y, Xu C, Zhao S, Li H, Zhang Y, Xu Y. The spectrum of angiography-derived IMR according to morphological and physiological coronary stenosis in patients with suspected myocardial ischemia. Clin Cardiol. 2023 May;46(5):502-511. doi: 10.1002/clc.23999. Epub 2023 Mar 1. PMID 36855931
Identifiers
NCT: NCT05435898 · NSS_2