Status:
COMPLETED
A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-90 years
Brief Summary
The purpose of this study is to demonstrate the impact of digital education on the cardiovascular risk factors in post-Myocardial Infarction patients and to generate evidence for broad implementation ...
Detailed Description
The local (Czech Republic), multi-center, prospective, descriptive study, is a non-treatment interventional, two-armed stratified randomized (1:1), not blinded, controlled (parallel group) study in ho...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 24 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06548555
Start Date
March 8 2023
End Date
October 24 2024
Last Update
December 13 2024
Active Locations (5)
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1
Novartis Investigative Site
Brno Bohunice, Czechia, 625 00
2
Novartis Investigative Site
České Budějovice, Czechia, 370 01
3
Novartis Investigative Site
Ostrava Poruba, Czechia, 708 52
4
Novartis Investigative Site
Prague, Czechia, 12808