A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients
NCT ID: NCT06548555
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2023-03-08
2024-10-24
Brief Summary
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Detailed Description
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The primary objective of the study is to describe the effect of the proposed educational program for post-MI patients on LDL-C at month 12 after the event compared to routine clinical practice.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Interventional arm
Patients receiving the systematic educational intervention
systematic educational intervention
This is a non-interventional study and does not impose a therapy protocol, or a diagnostic/therapeutic procedure. Patients are treated according to the local prescribing information, and routine medical practice in terms of visit frequency and types of assessments performed and only these data is collected as part of the study.
Control arm
Patients treated in the clinical routine mode (the education of the patient follows routine practice and no added education is provided by the Healthcare Professionals).
No interventions assigned to this group
Interventions
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systematic educational intervention
This is a non-interventional study and does not impose a therapy protocol, or a diagnostic/therapeutic procedure. Patients are treated according to the local prescribing information, and routine medical practice in terms of visit frequency and types of assessments performed and only these data is collected as part of the study.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Brno Bohunice, , Czechia
Novartis Investigative Site
České Budějovice, , Czechia
Novartis Investigative Site
Ostrava Poruba, , Czechia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Prague, , Czechia
Countries
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Other Identifiers
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CKJX839A1CZ01
Identifier Type: -
Identifier Source: org_study_id