Community-based Precise Management for Patients With Coronary Artery Disease

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05344053
• Collaborator: (none)
• Enrollment: 480
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 34.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Other: Community-based precise management; Other: Standard community-based management	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Development and Assessment of the Precise Management and Rehabilitation Model of Coronary Artery Disease Under the Hierarchical Medical System
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Status of risk factors control of coronary artery disease [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.

Secondary Outcome Measures

1. All-cause death [1 year]

2. Readmission [1 year]

3. Myocardial infarction [1 year]

4. Coronary revascularization [1 year]

5. Stroke [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Infirmary of Industrial and Commercial Bank of China	Beijing	Beijing	China	100037

Sponsors and Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haiyan Xu, Chief Physician, MD, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital
• ClinicalTrials.gov Identifier: NCT05344053
• Other Study ID Numbers: XCSTS-SD2020-11
• First Posted: Apr 25, 2022
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haiyan Xu, Chief Physician, MD, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital: Coronary Artery Disease; Risk Factor Control; Community-based Management; Secondary Prevention
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of May 6, 2022