Effect of Remote Intervention in Patients With SCAD

  • STATUS
    Recruiting
  • End date
    Apr 20, 2023
  • participants needed
    1000
  • sponsor
    Chinese Academy of Medical Sciences, Fuwai Hospital
Updated on 20 March 2021

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.

Details
Condition Coronary Artery Disease, Coronary heart disease, Vascular Diseases, Heart disease, Cardiovascular Disease, Ischemic Heart Disease, Stable Angina, Stable Angina Pectoris, Cardiac Ischemia, Myocardial Ischemia, Cardiac Disease, Stable Chronic Angina, cardiac diseases, heart diseases, cardiac disorders, cardiac disorder, heart disorder
Treatment remote intervention, Routine outpatient follow-up
Clinical Study IdentifierNCT04795492
SponsorChinese Academy of Medical Sciences, Fuwai Hospital
Last Modified on20 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 99 yrs?
Gender: Male or Female
Do you have any of these conditions: Heart disease or Vascular Diseases or heart disorder or Coronary Artery Disease or Coronary heart disease or Cardiac Disease or Cardiovascular Disease...?
Do you have any of these conditions: heart diseases or Cardiac Ischemia or cardiac disorders or Cardiac Disease or Ischemic Heart Disease or Coronary heart disease or Vascular Diseases or...?
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
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