A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels… (NCT06548555) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients
Czechia120 participantsStarted 2023-03-08
Plain-language 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 of the proposed education program.
Who can participate
Age range18 Years – 90 Years
SexALL
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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 interventio…
What they're measuring
1
Absolute change in LDL-C levels from baseline at month 12
Timeframe: Baseline, month 12
2
Relative (percentage) change in LDL-C levels from baseline at month 12