Effect of Remote Intervention in Patients With SCAD
Primary Purpose
Stable Chronic Angina, Ischemic Heart Disease, Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote intervention
Routine outpatient follow-up
Sponsored by
About this trial
This is an interventional prevention trial for Stable Chronic Angina
Eligibility Criteria
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
Sites / Locations
- Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular DiseasesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Remote intervention
Routine outpatient follow-up
Outcomes
Primary Outcome Measures
Medication adherence
Compliance and administration of cardiovascular protective drugs
Secondary Outcome Measures
Blood Pressure
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
standard protocol
LDL Cholesterol
standard protocol
HbA1c
standard protocol
Smoking
self-reported
Drinking
self-reported
Aspirin
self-reported
P2Y12 receptor antagonist
self-reported
Statin
self-reported
ACEI/ARB
self-reported
Beta-blocker
self-reported
MACCE
acute myocardial infarction, acute heart failure, rehospitalization for cardiovascular event, stroke, death from any cause, death from a cardiovascular cause and unplanned revascularization
Full Information
NCT ID
NCT04795492
First Posted
March 9, 2021
Last Updated
October 20, 2022
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04795492
Brief Title
Effect of Remote Intervention in Patients With SCAD
Official Title
Effect of Remote Intervention in Patients With SCAD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Chronic Angina, Ischemic Heart Disease, Coronary Artery Disease, Heart Diseases, Myocardial Ischemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Remote intervention
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Routine outpatient follow-up
Intervention Type
Behavioral
Intervention Name(s)
remote intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine outpatient follow-up
Intervention Description
Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention.
Primary Outcome Measure Information:
Title
Medication adherence
Description
Compliance and administration of cardiovascular protective drugs
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
BP was measured twice by an electronic device after 10 min of seated rest and calculated as the mean of 2 measurements
Time Frame
1 year
Title
Body Mass Index
Description
standard protocol
Time Frame
1 year
Title
LDL Cholesterol
Description
standard protocol
Time Frame
1 year
Title
HbA1c
Description
standard protocol
Time Frame
1 year
Title
Smoking
Description
self-reported
Time Frame
1 year
Title
Drinking
Description
self-reported
Time Frame
1 year
Title
Aspirin
Description
self-reported
Time Frame
1 year
Title
P2Y12 receptor antagonist
Description
self-reported
Time Frame
1 year
Title
Statin
Description
self-reported
Time Frame
1 year
Title
ACEI/ARB
Description
self-reported
Time Frame
1 year
Title
Beta-blocker
Description
self-reported
Time Frame
1 year
Title
MACCE
Description
acute myocardial infarction, acute heart failure, rehospitalization for cardiovascular event, stroke, death from any cause, death from a cardiovascular cause and unplanned revascularization
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boqun Shi, MD
Phone
+8615130119516
Email
shiboqun@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weihua Song, MD
Organizational Affiliation
Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boqun Shi, MD
Phone
+8615130119516
Email
shiboqun@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30998400
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.
Results Reference
background
PubMed Identifier
32745732
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.
Results Reference
background
PubMed Identifier
32858284
Citation
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.
Results Reference
background
Learn more about this trial
Effect of Remote Intervention in Patients With SCAD
We'll reach out to this number within 24 hrs