Community-based Precise Management for Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Official Title
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Development and Assessment of the Precise Management and Rehabilitation Model of Coronary Artery Disease Under the Hierarchical Medical System

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Community-based precise management
* Other: Standard community-based management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community-based precise management<br> | Other: Community-based precise management<br>* 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.<br>|
| Active Comparator: Standard community-based management<br> | Other: Standard community-based management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 1 year | 
| Readmission |  | 1 year | 
| Myocardial infarction |  | 1 year | 
| Coronary revascularization |  | 1 year | 
| Stroke |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Risk Factor Control, Community-based Management, Secondary Prevention