Effect of Remote Intervention in Patients With SCAD

Study Overview
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Brief Summary
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The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated a remote intervention with 1 year of follow-up.

Detailed Description
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Objective: This study is intended to verify the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease. Study design: The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease with 1 year of follow-up. Study intervention: Participants in the experimental group received remote guidance from the cardiac rehabilitation team in the community hospital every month after enrollment. The control group had no special intervention. All patients received follow-up at 6 months and 1-year follow-up. Outcome measures: The primary outcome was medication adherence. Secondary outcomes included smoking, drinking, blood pressure, body mass index, LDL cholesterol, HbA1c, and major adverse cerebral cardiovascular events(MACCE). Medication compliance consists of the following five medications: aspirin, P2Y12 receptor antagonist, statin, ACEI/ARB and beta-blocker. 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.

Official Title
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Effect of Remote Intervention in Patients With SCAD

Conditions
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Stable Chronic Angina, Ischemic Heart Disease, Coronary Artery Disease, Heart Diseases, Myocardial Ischemia

Intervention / Treatment
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* Behavioral: remote intervention
* Behavioral: Routine outpatient follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18-99 years 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) Have sufficient Chinese language proficiency to reading, speaking and listening Live with at least one caregiver or guardian in the household Presence of stable hemodynamics without using vasopressor Able to individually consent Not participating in any other clinical trial Exclusion Criteria: Unable to provide informed consent Unable to be involved in clinical follow-up and treatment Suffered comorbidity with a life expectancy of less than 1 year Have contra-indication to cardiac rehabilitation Acute coronary syndrome History of noncompliance with medical therapy Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial Planned major surgery necessitating interruption of antiplatelet therapy Inability to comply with the protocol Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject or that could prevent, limit or confound the protocol-specified assessments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Remote intervention | Behavioral: remote intervention<br>* Medication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided. Risk factor modification included lipid control, smoking and drinking cessation, BP monitoring, dietary change keeping a healthy weight and in our trial. There were also a lot of educational materials about coronary heart disease knowledge that were reviewed by cardiologists, and participants were free to provide them whenever and wherever they want.<br>|
| Active Comparator: Control group<br>Routine outpatient follow-up | Behavioral: Routine outpatient follow-up<br>* Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | Compliance and administration of cardiovascular protective drugs | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | BP was measured twice by an electronic device after 10 min of seated rest and calculated as the mean of 2 measurements | 1 year | 
| Body Mass Index | standard protocol | 1 year | 
| LDL Cholesterol | standard protocol | 1 year | 
| HbA1c | standard protocol | 1 year | 
| Smoking | self-reported | 1 year | 
| Drinking | self-reported | 1 year | 
| Aspirin | self-reported | 1 year | 
| P2Y12 receptor antagonist | self-reported | 1 year | 
| Statin | self-reported | 1 year | 
| ACEI/ARB | self-reported | 1 year | 
| Beta-blocker | self-reported | 1 year | 
| MACCE | acute myocardial infarction, acute heart failure, rehospitalization for cardiovascular event, stroke, death from any cause, death from a cardiovascular cause and unplanned revascularization | 1 year |