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Community-based Precise Management for Patients With Coronary Artery Disease

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Community-based precise management
Standard community-based management
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Risk Factor Control, Community-based Management, Secondary Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Infirmary of Industrial and Commercial Bank of ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Community-based precise management

Standard community-based management

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All-cause death
Readmission
Myocardial infarction
Coronary revascularization
Stroke

Full Information

First Posted
April 19, 2022
Last Updated
May 4, 2022
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05344053
Brief Title
Community-based Precise Management for Patients With Coronary Artery Disease
Official Title
Development and Assessment of the Precise Management and Rehabilitation Model of Coronary Artery Disease Under the Hierarchical Medical System
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Risk Factor Control, Community-based Management, Secondary Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Community-based precise management
Arm Type
Experimental
Arm Title
Standard community-based management
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Community-based precise management
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard community-based management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Status of risk factors control of coronary artery disease
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
All-cause death
Time Frame
1 year
Title
Readmission
Time Frame
1 year
Title
Myocardial infarction
Time Frame
1 year
Title
Coronary revascularization
Time Frame
1 year
Title
Stroke
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyan Xu, MD, PhD
Phone
8610-88396082
Email
xuhaiyan@fuwaihospital.org
Facility Information:
Facility Name
Infirmary of Industrial and Commercial Bank of China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Xu, MD, PhD
Phone
8610-88396082
Email
xuhaiyan@fuwaihospital.org

12. IPD Sharing Statement

Learn more about this trial

Community-based Precise Management for Patients With Coronary Artery Disease

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