Community-based Precise Management for Patients With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05344053
• Other study ID #: XCSTS-SD2020-11
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2022
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Haiyan Xu, MD, PhD
• Phone: 8610-88396082
• Email: xuhaiyan[@]fuwaihospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Community-based precise management
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 management
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.

Locations

Country	Name	City	State
China	Infirmary of Industrial and Commercial Bank of China	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause death		1 year
Secondary	Readmission		1 year
Secondary	Myocardial infarction		1 year
Secondary	Coronary revascularization		1 year
Secondary	Stroke		1 year