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

A Prospective Multicentric Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients in the Czech Republic

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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 hospitalized adult patients after first myocardial infarction with two arms to evaluate the effect of systematic education program on the 12-months change of LDL-C. Patients are recruited (randomized) into two arms: interventional and control. The interventional arm receives the systematic educational intervention. The control arm is treated in the clinical routine mode, i.e., the education of the patient follows routine practice and no added education are provided by the HCPs (Healthcare Professionals). The post-MI treatment in both arms follows the standard of care (SOC). The End of Study (EOS) visit will be performed at month 12 at the place of the initial hospitalization. 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

• Myocardial Infarction

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2023-03-08
• Primary completion: 2024-10-24
• Completion: 2024-10-24
• First posted: 2024-08-12
• Last updated: 2024-12-13

Locations

5 sites across 1 country: Czechia