Effect of Remote Intervention in Patients With SCAD

Not Applicable

Withdrawn

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

• Registration Number: NCT04795492
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Study Start: 2021-04-01
• Primary Completion: 2023-04
• Study Completion: 2023-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication adherence	1 year	Compliance and administration of cardiovascular protective drugs

Secondary Outcome Measures

Name	Time	Method
LDL Cholesterol	1 year	standard protocol
Aspirin	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
Body Mass Index	1 year	standard protocol
HbA1c	1 year	standard protocol
Drinking	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
P2Y12 receptor antagonist	1 year	self-reported
Smoking	1 year	self-reported

Trial Locations

Locations (1)

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