Study Stopped
Unable to recruit enough patients
Effect of Remote Intervention in Patients With SCAD
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedFebruary 8, 2024
February 1, 2024
2 years
March 9, 2021
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Medication adherence
Compliance and administration of cardiovascular protective drugs
1 year
Secondary Outcomes (12)
Blood Pressure
1 year
Body Mass Index
1 year
LDL Cholesterol
1 year
HbA1c
1 year
Smoking
1 year
- +7 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALRemote intervention
Control group
ACTIVE COMPARATORRoutine outpatient follow-up
Interventions
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.
Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100000, China
Related Publications (3)
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.
PMID: 30998400BACKGROUNDYu 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.
PMID: 32745732BACKGROUNDChen 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.
PMID: 32858284BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weihua Song, MD
Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 12, 2021
Study Start
April 1, 2021
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
February 8, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share