Effect of Remote Intervention in Patients With SCAD

Coronary Artery Disease Clinical Trial

Official title:

Effect of Remote Intervention in Patients With SCAD

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04795492
• Other study ID #: ERIP
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 2023

Study information

• Verified date: February 2024
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• remote 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.
• Routine outpatient follow-up
Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention.

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Chen X, Zhou X, Li H, Li J, Jiang H. The value of WeChat application in chronic diseases management in China. Comput Methods Programs Biomed. 2020 Nov;196:105710. doi: 10.1016/j.cmpb.2020.105710. Epub 2020 Aug 14. — View Citation

Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4. — View Citation

Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005616. doi: 10.1161/CIRCOUTCOMES.119.005616. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	Compliance and administration of cardiovascular protective drugs	1 year
Secondary	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
Secondary	Body Mass Index	standard protocol	1 year
Secondary	LDL Cholesterol	standard protocol	1 year
Secondary	HbA1c	standard protocol	1 year
Secondary	Smoking	self-reported	1 year
Secondary	Drinking	self-reported	1 year
Secondary	Aspirin	self-reported	1 year
Secondary	P2Y12 receptor antagonist	self-reported	1 year
Secondary	Statin	self-reported	1 year
Secondary	ACEI/ARB	self-reported	1 year
Secondary	Beta-blocker	self-reported	1 year
Secondary	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