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NCT Number: NCT05919056

Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

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.

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Key information

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yinzhou District Center for Disease Control and Prevention

Ningbo, Zhejiang, 315100, China

Location status: Recruiting

Location contact

Peng SHEN, MPH

CONTACT

[email protected]

+86-574-87418718

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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%);

Exclusion criteria

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

Treatment and study plan

Frequent and automatic cardiovascular risk assessment

Other

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.

Dynamic risk monitoring

Other

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).

Regular GP visits

Other

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").

Primary outcomes

  1. Primary Outcome of Phase I: Change in cardiovascular risk score

    Time frame: 24 months after baseline

    The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts

  2. Primary Outcome of Phase II: Major adverse cardiovascular events (MACE)

    Time frame: 60 months after baseline

    Incidence of coronary heart disease, stroke, heart failure and all-cause mortality

Secondary outcomes

  1. Secondary Outcome of Phase I: Change in systolic blood pressure

    Time frame: 24 months after baseline

    the change in systolic blood pressure from baseline

  2. Secondary Outcome of Phase I: Change in total cholesterol

    Time frame: 24 months after baseline

    the change in total cholesterol from baseline

  3. Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol

    Time frame: 24 months after baseline

    the change in low-density lipoprotein cholesterol from baseline

  4. Secondary Outcome of Phase II: Change in health-related quality of life

    Time frame: 60 months after baseline

    Measured using the EuroQol-5 Dimensions-5L(EQ-5D)

Other outcomes

  1. Other Pre-specified Outcome of Phase II: Incremental cost-effectiveness ratio (ICER)

    Time frame: 60 months after baseline

    the incremental cost-effectiveness ratio (ICER) of the management provided by the interventions compared to the usual care

Study contacts

Contact information is provided by the study sponsor or research team.

Xun TANG, PhD, MHS

CONTACT

[email protected]

+86-10-82801528 ext 317

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Yinzhou District Center for Disease Control and Prevention

Registry information

Official study title

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

Acronym: CRITICALLY

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2023
Registry last updated
Nov 15, 2024

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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