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Completed
NCT06548555
A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients
Conditions: Myocardial Infarction
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Enrollment: 121
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site Brno-Bohunice
Summary
The purpose of this study was to demonstrate the impact of digital education on the cardiovascular risk factors in post-Myocardial Infarction patients and to generate evidence for broad implementation of the proposed education program.
Eligibility Criteria
Inclusion Criteria:
Participants eligible for inclusion in this study must fulfil all the following criteria:
* Male or female patients ≥18 years of age,
* At the Screening Visit, participants must be hospitalized for the first myocardial infarction. This must be a spontaneous MI (either ST-elevation MI or non-ST-elevation MI), which was not the result of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). Confirmation of MI is a combination of signs or symptoms consistent with presentation of MI, and at least one of the following (adapted from (Thygesen, et al., 2018)):
* Documentation of cardiac biomarkers that exceed the diagnostic threshold of a local laboratory for MI
* Pathological Q waves on ECG or other ECG changes as defined in Appendix 2
* Imaging evidence of loss of viable myocardium or regional wall motion abnormality in a pattern consistent with an infarction or ischemic etiology
* Identification of a coronary thrombus by angiography at the time of presentation with MI,
* LDL-C ≥ 1.8 mmol/L at the time of the hospitalization,
* Ability to participate in the hybrid educational program (must be able to receive emails and watch online educational videos),
* Patients must provide written consent to participate in the study.
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this study:
* History of previous myocardial infarction,
* History of previous coronary intervention due to ASCVD (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)),
* History of ischemic stroke,
* Any surgical or medical condition, which in the opinion of the investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study,
* Patients diagnosed with homozygous familial hypercholesterolemia,
* Unwillingness or inability (e.g., physical, or cognitive) to comply with study procedures (including adherence to study visits and fasting blood draws) and schedule,
* Participation in any other interventional study, both treatment and non-treatment interventional study,
* Patients treated with inclisiran prior to the hospitalization for myocardial infarction.
Source: ClinicalTrials.gov (NCT06548555). StuddyBuddy aggregates publicly available trial information.