Coronary Artery Disease, Heart Diseases, Ischemic Heart Disease, Myocardial Ischemia, Stable Chronic Angina
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALremote intervention
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.
BEHAVIORALRoutine outpatient follow-up
Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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 6. History of noncompliance with medical therapy 7. Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial 8. Planned major surgery necessitating interruption of antiplatelet therapy 9. Inability to comply with the protocol 10. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence | 1 year | Compliance and administration of cardiovascular protective drugs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | 1 year | standard protocol |
| LDL Cholesterol | 1 year | standard protocol |
| HbA1c | 1 year | standard protocol |
| Smoking | 1 year | self-reported |
| Drinking | 1 year | self-reported |
| 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 |
| P2Y12 receptor antagonist | 1 year | self-reported |
| Statin | 1 year | self-reported |
| ACEI/ARB | 1 year | self-reported |
| Beta-blocker | 1 year | self-reported |
| MACCE | 1 year | acute myocardial infarction, acute heart failure, rehospitalization for cardiovascular event, stroke, death from any cause, death from a cardiovascular cause and unplanned revascularization |
| Aspirin | 1 year | self-reported |
Countries
China
Outcome results
None listed