Community-based Precise Management for Patients With Coronary Artery Disease

NCT ID: NCT05344053

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-07-01

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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Community-based precise management

Group Type EXPERIMENTAL

Community-based precise management

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Standard community-based management

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Haiyan Xu

Chief Physician, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Infirmary of Industrial and Commercial Bank of China

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haiyan Xu, MD, PhD

Role: CONTACT

8610-88396082

Facility Contacts

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Haiyan Xu, MD, PhD

Role: primary

8610-88396082

Other Identifiers

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XCSTS-SD2020-11

Identifier Type: -

Identifier Source: org_study_id

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