Coronary Artery DiseaseNCT05344053
Community-based Precise Management for Patients With Coronary Artery Disease
A study testing Community-based precise management and Standard community-based management in people with Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The community-based precise management for patients with coronary artery disease study is a prospective, cluster-randomized, open-labeled trial. The purpose of this trial is to test whether a community-based precise management and rehabilitation model under the hierarchical medical system could help improve the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Community-based precise management and Standard community-based management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with prior myocardial infarction
- or receiving percutaneous coronary intervention or coronary artery bypass graft;
- or coronary artery stenosis≥50% defined by coronary angiography or coronary CT angiography
Who cannot join
- Refuse to sign the written informed consent;
- Patients without the ability to take care of themselves;
- Mental disorders;
- Alcoholics or drug addicts;
- Cannot be followed up for any reasons;
- Life expectancy<1 year due to non-cardiovascular reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Infirmary of Industrial and Commercial Bank of China
Beijing, Beijing Municipality, 100037
Haiyan Xu, MD, PhD, 8610-88396082, xuhaiyan@fuwaihospital.org
About this study
Official title: Development and Assessment of the Precise Management and Rehabilitation Model of Coronary Artery Disease Under the Hierarchical Medical System
The community-based precise management for patients with coronary artery disease study is a prospective, cluster-randomized, open-labeled trial. The purpose of this trial is to test whether a community-based precise management and rehabilitation model under the hierarchical medical system could help improve the cardiovascular risk factors control in patients with coronary artery disease. Additionally, the trial will also evaluate the impact of the model on major cardiovascular adverse events in patients with coronary artery disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Community-based precise management, Standard community-based management
- Keywords
- Coronary Artery Disease, Risk Factor Control, Community-based Management, Secondary Prevention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based precise managementOther
The community-based precise management is a modified management strategy beyond the traditional standard community-based care under the hierarchical medical system of China. In the intervention arm, the community doctors receive training to improve their skills on coronary artery disease management. Patients will be under management for 1 year according to the strategies of community-based precise management and rehabilitation model.
Standard community-based managementOther
The standard community-based management is the usual community-based care under the hierarchical medical system of China. In this arm, the community doctors will not receive any training on precise management strategies to improve their skills on coronary artery disease management, and patients will be under usual care for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Community-based precise management | Experimental | Not described Receives: Other: Community-based precise management |
| Standard community-based management | Active comparator | Not described Receives: Other: Standard community-based management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of risk factors control of coronary artery disease
A composite of not smoking, blood pressure<140/90mmHg/<130/80mmHg for patients with diabetes, HbA1c≤7%, LDL-C<1.8mmol/L, antiplatelet therapy, and statins use.
Measured: 1 year
Secondary outcomes (5)
All-cause death
Measured: 1 year
Readmission
Measured: 1 year
Myocardial infarction
Measured: 1 year
Coronary revascularization
Measured: 1 year
Stroke
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiyan Xu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344053
- Sponsor's protocol ID
- XCSTS-SD2020-11
- Status last verified
- May 2022
- First submitted
- 19 Apr 2022
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Assessment of the Precise Management and Rehabilitation Model of Coronary Artery Disease Under the Hierarchical Medical System
- ClinicalTrials.gov ID
- NCT05344053
- Acronym / sponsor ID
- XCSTS-SD2020-11
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Risk Factor Control, Community-based Management, Secondary Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 25 Apr 2022 (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.
The community-based precise management for patients with coronary artery disease study is a prospective, cluster-randomized, open-labeled trial. The purpose of this trial is to test whether a community-based precise management and rehabilitation model under the hierarchical medical system could help improve the cardiovascular risk factors control in patients with coronary artery disease. Additionally, the trial will also evaluate the impact of the model on major cardiovascular adverse events in patients with coronary artery disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-based precise management | Experimental | Other: Community-based precise management |
| Standard community-based management | Active comparator | Other: Standard community-based management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with prior myocardial infarction
- or receiving percutaneous coronary intervention or coronary artery bypass graft;
- or coronary artery stenosis≥50% defined by coronary angiography or coronary CT angiography
Key exclusion criteria (6 listed)
- Refuse to sign the written informed consent;
- Patients without the ability to take care of themselves;
- Mental disorders;
- Alcoholics or drug addicts;
- Cannot be followed up for any reasons;
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 |
|---|---|---|
| Community-based precise managementThe community-based precise management is a modified management strategy beyond the traditional standard community-based care under the hierarchical medical system of China. In the intervention arm, the community doctors receive training to improve their skills on coronary artery disease management. Patients will be under management for 1 year according to the strategies of community-based precise management and rehabilitation model. | Other | Community-based precise management |
| Standard community-based managementThe standard community-based management is the usual community-based care under the hierarchical medical system of China. In this arm, the community doctors will not receive any training on precise management strategies to improve their skills on coronary artery disease management, and patients will be under usual care for 1 year. | Other | Standard community-based management |
Primary outcome
Status of risk factors control of coronary artery disease
Time frame: 1 year
A composite of not smoking, blood pressure<140/90mmHg/<130/80mmHg for patients with diabetes, HbA1c≤7%, LDL-C<1.8mmol/L, antiplatelet therapy, and statins use.
5 secondary outcomes
All-cause death
Time frame: 1 year
Readmission
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Coronary revascularization
Time frame: 1 year
Stroke
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
Related trials for Coronary Artery Disease
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based precise management and Standard community-based management in people with Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 6 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Xu, MD, PhD (8610-88396082, xuhaiyan@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of risk factors control of coronary artery disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2022.