Clinical trial NCT04795492: Effect of Remote Intervention in Patients With SCAD
Official title: Effect of Remote Intervention in Patients With SCAD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stable Chronic Angina
Ischemic Heart Disease
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication adherence
timeFrame: 1 year
Secondary outcomes:
measure: Blood Pressure
timeFrame: 1 year
measure: Body Mass Index
timeFrame: 1 year
measure: LDL Cholesterol
timeFrame: 1 year
measure: HbA1c
timeFrame: 1 year
measure: Smoking
timeFrame: 1 year
measure: Drinking
timeFrame: 1 year
measure: Aspirin
timeFrame: 1 year
measure: P2Y12 receptor antagonist
timeFrame: 1 year
measure: Statin
timeFrame: 1 year
measure: ACEI/ARB
timeFrame: 1 year
measure: Beta-blocker
timeFrame: 1 year
measure: MACCE
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
name: Weihua Song, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.