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A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients
A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients
CompletedN/A
Sponsor: Novartis Pharmaceuticals
Conditions: Myocardial Infarction
Interventions: systematic educational intervention
Countries: Czechia
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 overview
Sex: ALL
Age: 18 Years to 90 Years
Healthy volunteers: No
Study type: OBSERVATIONAL
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.
Locations (5)
- Brno-Bohunice, Czechia
- České Budějovice, Czechia
- Ostrava Poruba, Czechia
- Prague, Czechia
- Prague, Czechia