A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients (DEDUCA-CZ)

Novartis

Status: Completed

Conditions: Myocardial Infarction

Treatments: Other: systematic educational intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06548555

CKJX839A1CZ01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Interventional arm

Description:

Patients receiving the systematic educational intervention

Treatment:

Other: systematic educational intervention

Control arm

Description:

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).