Effect of Tertiary A-level Hospital Remote Intervention on MACCE, Adherence to Drugs and Risk Factors Control in Patients With Stable Coronary Artery Disease Compared With Traditional Community Hospital Follow-up

Completed

• Conditions: Ischemic Heart Disease; Stable Chronic Angina; Acute Coronary Syndrome

• Registration Number: NCT04795505
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

The study was a multicenter, two-arm, parallel, open label, prospective study intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.

Detailed Description

Objective: This study is intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.

Study design: The study was a multicenter, two-arm, parallel, open label, prospective study that evaluated a WeChat-based intervention offered by tertiary A-level hospital with 1 year of follow-up.

Study intervention: All patients received lifestyle intervention and drug adjustment at 1 month, 3 months, 6 months and 1 year follow-up. In the control group, the subsequent visit was through an offline outpatient clinic at 4 different community hospitals. Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention. While in the intervention group, the subsequent visit was through WeChat-based online consultations.

Outcome measures: The primary outcome was MACCE. Secondary outcome included blood pressure, heart rates, smoking cessation, drinking cessation, body mass index, and medications adherence.

Statistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1424

Inclusion Criteria

1. aged between 18-99 years
2. diagnosed with SCAD according to guidelines by coronary CTA or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome)
3. have sufficient Chinese language proficiency to reading, speaking and listening
4. live with at least one caregiver or guardian in the household
5. presence of stable hemodynamics without using vasopressor
6. able to individually consent
7. not participating in any other clinical trial

Exclusion Criteria

1. unable to provide informed consent
2. unable to be involved in clinical follow up and treatment
3. suffered comorbidity with a life expectancy of less than 1 year
4. have contra-indication to cardiac rehabilitation
5. acute coronary syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACCE	1 year	acute myocardial infarction, acute heart failure, stroke, rehospitalization for cardiovascular event, death from a cardiovascular cause and unplanned revascularization

Secondary Outcome Measures

Name	Time	Method
drinking cessation	1 year	self-reported
body mass index	1 year	standard protocol
LDL	1 year	standard protocol
HbA1c	1 year	standard protocol
blood pressure	1 year	BP was measured twice by an electronic device after 10 min of seated rest and calculated as the mean of 2 measurements.
heart rates	1 year	standard protocol
smoking cessation	1 year	self-reported
medications adherence	1 year	self-reported

Trial Locations

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases; 🇨🇳 Beijing, Beijing, China