Effect of Remote Intervention in Patients With SCAD

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Withdrawn

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

Treatments: Behavioral: remote intervention; Behavioral: Routine outpatient follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT04795492

ERIP

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Intervention group

Experimental group

Description:

Remote intervention

Treatment:

Behavioral: remote intervention

Control group

Active Comparator group

Description:

Routine outpatient follow-up

Treatment:

Behavioral: Routine outpatient follow-up