Cardiovascular DiseasesCRITICALLYNCT05919056

Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

A study testing Frequent and automatic cardiovascular risk assessment, Dynamic risk monitoring and Regular GP visits in people with Cardiovascular Diseases, run by Peking University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 40 to 79 years
Conditions the study is for: Cardiovascular Diseases
What is being tested?: Frequent and automatic cardiovascular risk assessment, Dynamic risk monitoring and Regular GP visits
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22,032 participants
Where: 1 siteChina
Study dates: 6 Jul 2023to 1 Jul 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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%);

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xun TANG, PhD, MHS contact

+86-10-82801528 ext 317

tangxun@bjmu.edu.cn

China1 site, 1 recruiting

Yinzhou District Center for Disease Control and Prevention
Ningbo, Zhejiang, 315100
Peng SHEN, MPH, +86-574-87418718, shen-peng@foxmail.com
Recruiting

Other trials in China

About this study

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

Read the detailed description

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.

Conditions: Cardiovascular Diseases
Being tested: Frequent and automatic cardiovascular risk assessment, Dynamic risk monitoring, Regular GP visits
Keywords: primary prevention, cluster randomized trial, cardiovascular risk assessment
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Frequent and automatic cardiovascular risk assessmentOther
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 monitoringOther
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 visitsOther
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").

Study groups in NCT05919056
Study group	Role	What they receive
Intervention arm	Experimental	The interventions include cardiovascular risk assessment, dynamic risk monitoring, and regular general practitioner (GP) visits. The frequency of risk assessment, risk monitoring, and automatic mobile texting will be once per month, while regular GP visits will be once per three months. Receives: Other: Frequent and automatic cardiovascular risk assessment; Other: Dynamic risk monitoring; Other: Regular GP visits
Control arm	No intervention	Current regular management (usual care) will be kept in the control arm. The management objectives are for patients with hypertension or diabetes mellitus. The frequency of follow-up is at least once per three months.

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Outcome of Phase I: Change in cardiovascular risk score
The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts
Measured: 24 months after baseline
Primary Outcome of Phase II: Major adverse cardiovascular events (MACE)
Incidence of coronary heart disease, stroke, heart failure and all-cause mortality
Measured: 60 months after baseline

Secondary outcomes (4)

Secondary Outcome of Phase I: Change in systolic blood pressure
the change in systolic blood pressure from baseline
Measured: 24 months after baseline
Secondary Outcome of Phase I: Change in total cholesterol
the change in total cholesterol from baseline
Measured: 24 months after baseline
Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol
the change in low-density lipoprotein cholesterol from baseline
Measured: 24 months after baseline
Secondary Outcome of Phase II: Change in health-related quality of life
Measured using the EuroQol-5 Dimensions-5L(EQ-5D)
Measured: 60 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 20231 Jul 2028

First posted26 Jun 2023
Study start6 Jul 2023
Primary completion1 Jul 2028 (estimated)
Study completion1 Jul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by Peking UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 22,032 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05919056
Sponsor's protocol ID: IRB00001052-21060
Acronym: CRITICALLY
Status last verified: Sep 2026
First submitted: 16 Jun 2023
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: According to the Administrative Regulations on Human Genetic Resources issued by the State Council of the People's Republic of China in 2019, we are waiting for the approval of IPD sharing.

Publications

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.
PubMed 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.
PubMed 36340248

Interested in taking part?

Xun TANG, PhD, MHS

+86-10-82801528 ext 317

tangxun@bjmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardiovascular Risk Assessment and dynamIc Monitoring-based Prevention Trial for prImary Care quALity evaLuation in Yinzhou
ClinicalTrials.gov ID: NCT05919056
Acronym / sponsor ID: CRITICALLY / IRB00001052-21060
Conditions: Cardiovascular Diseases
Keywords: primary prevention, cluster randomized trial, cardiovascular risk assessment
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 22,032 participants (estimated)
Lead sponsor: Peking UniversityUniversity, hospital or other
Collaborators: Center for Disease Control and Prevention of Yinzhou District, Ningbo City, China
Study start: 6 Jul 2023 (actual)
Primary completion: 1 Jul 2028 (estimated)
Study completion: 1 Jul 2028 (estimated)
First posted: 26 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention arm	Experimental	Other: Frequent and automatic cardiovascular risk assessment, Other: Dynamic risk monitoring, Other: Regular GP visitsThe interventions include cardiovascular risk assessment, dynamic risk monitoring, and regular general practitioner (GP) visits. The frequency of risk assessment, risk monitoring, and automatic mobile texting will be once per month, while regular GP visits will be once per three months.
Control arm	No intervention	–Current regular management (usual care) will be kept in the control arm. The management objectives are for patients with hypertension or diabetes mellitus. The frequency of follow-up is at least once per three months.

Who may qualify

Ages: 40 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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%);

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Frequent and automatic cardiovascular risk assessmentThe 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.	Other	Intervention arm
Dynamic risk monitoringHigh-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).	Other	Intervention arm
Regular GP visitsThe 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").	Other	Intervention arm

Primary outcome

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
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

4 secondary outcomes

Secondary Outcome of Phase I: Change in systolic blood pressure
Time frame: 24 months after baseline
Secondary Outcome of Phase I: Change in total cholesterol
Time frame: 24 months after baseline
Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol
Time frame: 24 months after baseline
Secondary Outcome of Phase II: Change in health-related quality of life
Time frame: 60 months after baseline

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Background: PubMed 29440217Lin 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.
BackgroundLiu 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.
Background: PubMed 36340248Liu 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.
Individual participant dataSharing planned: No. According to the Administrative Regulations on Human Genetic Resources issued by the State Council of the People's Republic of China in 2019, we are waiting for the approval of IPD sharing.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Xun TANG, PhD, MHS contact

+86-10-82801528 ext 317

tangxun@bjmu.edu.cn

Xun TANG, PhD, MHS principal investigator

Pei GAO, PhD principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xun TANG, PhD, MHS (+86-10-82801528 ext 317, tangxun@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome of Phase I: Change in cardiovascular risk score (time frame: 24 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05919056, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.