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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06548555). StuddyBuddy aggregates publicly available trial information.