Community-based Precise Management for Patients With Coronary Artery Disease

May 4, 2022 updated by: Haiyan Xu, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Infirmary of Industrial and Commercial Bank of China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Community-based precise management
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.
ACTIVE_COMPARATOR: Standard community-based management
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (ACTUAL)

April 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XCSTS-SD2020-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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