Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

Официальное название

Cardiovascular Risk Assessment and dynamIc Monitoring-based Prevention Trial for prImary Care quALity evaLuation in Yinzhou

Обзор

The CRITICALLY study is a cluster randomized trial that will evaluate the effectiveness of a risk-based dynamic monitoring strategy for the primary prevention of cardiovascular high-risk Chinese adults.

Подробное описание

The objective of the study is to evaluate the effectiveness of a risk-based management strategy on cardiovascular risk scores (calculated by the 2019 WHO cardiovascular risk charts) in 24 months (Phase I) and the incidence of major adverse cardiovascular events in 60 months (Phase II). Totally 216 clinics in Yinzhou District, China will be randomized to the intervention or the control arms with usual care. The interventions supported by the web-based decision support system include (1) cardiovascular risk assessment, (2) dynamic risk monitoring, and (3) regular visits by the general practitioner every three months. Only usual care will be provided in the control arm. The primary outcome is the change in cardiovascular risk scores for Phase I and the incidence of the composite endpoint of coronary heart disease, stroke, heart failure and all-cause mortality for Phase II. If the comprehensive strategy is proven effective, it could provide evidence for the primary prevention of cardiovascular diseases using digital health technology.

Вмешательства

• Другое Frequent and automatic cardiovascular risk assessment
  The 10-year cardiovascular risk scores using the 2019 World Health Organization (WHO) laboratory-based risk charts will be automatically calculated using the latest health information on an EHR-based system per month.
• Другое Dynamic risk monitoring
  High-risk individuals will be reassessed by the Dynamic Risk-based Early wArning and Monitoring (DREAM) system to obtain the short-term risk. The DREAM system will send a text message about advice to the high-risk individual every month. The text message includes information on the health status (e.g., current cardiovascular risk, level of blood pressure and lipid) and real-time warning messages (e.g., high short-term risk).
• Другое Regular GP visits
  The general practitioners will communicate with the participants based on the information automatically generated from the DREAM system every three months: each participant's cardiovascular risk score, health status (e.g., diabetes mellitus and/or hypertension), and Chinese guidelines-based recommendations (e.g., "for the management of dyslipidemia, to provide clear treatment targets for high-risk participants").

Первичные конечные точки

• Primary Outcome of Phase I: Change in cardiovascular risk score [Срок оценки: 24 months after baseline]
• Primary Outcome of Phase II: Major adverse cardiovascular events (MACE) [Срок оценки: 60 months after baseline]

Вторичные конечные точки (4)

• Secondary Outcome of Phase I: Change in systolic blood pressure [Срок оценки: 24 months after baseline]
• Secondary Outcome of Phase I: Change in total cholesterol [Срок оценки: 24 months after baseline]
• Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol [Срок оценки: 24 months after baseline]
• Secondary Outcome of Phase II: Change in health-related quality of life [Срок оценки: 60 months after baseline]

Критерии участия

Критерии включения

• Residents in the Yinzhou District have a unique health ID;
• Aged 40 to 79 years at the baseline enrollment;
• With high risk of cardiovascular disease evaluated by the 2019 WHO laboratory-based risk models (10-year risk≥10%);

Критерии исключения

• Have a history of coronary heart disease, stroke or heart failure;
• Patients with a diagnosis of cancer;
• Refused to provide written informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Yinzhou District Center for Disease Control and Prevention — Ningbo

Публикации

• Lin H, Tang X, Shen P, Zhang D, Wu J, Zhang J, Lu P, Si Y, Gao P. Using big data to improve cardiovascular care and outcomes in China: a protocol for the CHinese Electronic health Records Research in Yinzhou (CHERRY) Study. BMJ Open. 2018 Feb 12;8(2):e019698. doi: 10.1136/bmjopen-2017-019698. PMID 29440217
• Liu XF, Li QQ, Chen WY, et al. A dynamic risk-based early warning monitoring system for population-based management of cardiovascular disease. Fundamental Research. 2021:534-542.
• Liu X, Shen P, Zhang D, Sun Y, Chen Y, Liang J, Wu J, Zhang J, Lu P, Lin H, Tang X, Gao P. Evaluation of Atherosclerotic Cardiovascular Risk Prediction Models in China: Results From the CHERRY Study. JACC Asia. 2022 Jan 4;2(1):33-43. doi: 10.1016/j.jacasi.2021.10.007. eCollection 2022 Feb. PMID 36340248

Идентификаторы

NCT: NCT05919056 · IRB00001052-21060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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