Community-based Precise Management for Patients With Coronary Artery Disease
Development and Assessment of the Precise Management and Rehabilitation Model of Coronary Artery Disease Under the Hierarchical Medical System
1 other identifier
interventional
480
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started May 2022
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedMay 6, 2022
May 1, 2022
1.1 years
April 19, 2022
May 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
All-cause death
1 year
Readmission
1 year
Myocardial infarction
1 year
Coronary revascularization
1 year
Stroke
1 year
Study Arms (2)
Community-based precise management
EXPERIMENTALStandard community-based management
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Infirmary of Industrial and Commercial Bank of China
Beijing, Beijing Municipality, 100037, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician, MD, PhD
Study Record Dates
First Submitted
April 19, 2022
First Posted
April 25, 2022
Study Start
May 1, 2022
Primary Completion
June 1, 2023
Study Completion
July 1, 2023
Last Updated
May 6, 2022
Record last verified: 2022-05