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)

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

The purpose of this study was 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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: systematic educational intervention

Detailed Description

The local (Czech Republic), multi-center, prospective, descriptive study, was 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 were recruited (randomized) into two arms: interventional and control. The interventional arm received the systematic educational intervention. The control arm was treated in the clinical routine mode, i.e., the education of the patient followed routine practice and no added education was provided by the HCPs (Healthcare Professionals). The post-MI treatment in both arms followed the standard of care (SOC). The End of Study (EOS) visit was performed at month 12 at the place of the initial hospitalization.

The primary objective of the study was 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.

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• Czechia
  • Brno-Bohunice, Czechia, 625 00
    • Novartis Investigative Site
  • Ostrava Poruba, Czechia, 708 52
    • Novartis Investigative Site
  • Prague, Czechia, 12808
    • Novartis Investigative Site
  • Prague, Czechia, 150 30
    • Novartis Investigative Site
  • České Budějovice, Czechia, 370 01
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients after the first myocardial infarction.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).
Interventional arm; Patients received the systematic educational intervention	Other: systematic educational intervention; This was a non-interventional study and did not impose a therapy protocol, or a diagnostic/therapeutic procedure. Patients were 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 was collected as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in LDL-C levels from baseline at month 12	Absolute change in LDL-C levels from baseline at month 12 after the event.	Baseline, month 12
Relative (percentage) change in LDL-C levels from baseline at month 12	Relative change in LDL-C levels from baseline at month 12 after the event.	Baseline, month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving their LDL-C target level	Percentage of patients achieving their LDL-C target level according to the 2019 ESC/EAS Guidelines (LDL-C reduction of ≥50% from baseline and an LDL-C goal of <1.4 mmol/L)	Month 12
Change in total cholesterol from Baseline at Month 12	Change in total cholesterol from Baseline at Month 12	Baseline, month 12
Change in HDL-C from Baseline at month 12	Change in high-density lipoprotein cholesterol (HDL-C)	Baseline, month 12
Change in VLDL-C from Baseline at month 12	Change in very low- density lipoprotein cholesterol (VLDL-C).	Baseline, month 12
Change in non-HDL-C from Baseline at month 12	Change in non-high-density lipoprotein cholesterol (non-HDL-C).	Baseline, month 12
Change in triglycerides from Baseline at month 12	Change in triglycerides	Baseline, month 12
Change in Lp(a) from Baseline at month 12	Change in lipoprotein(a) [Lp(a)])	Baseline, month 12
Blood pressure	Blood pressure at baseline and month 12 will be provided	Baseline, month 12
Body Mass Index	BMI (Body Mass Index) at baseline and month 12 will be provided	Baseline, month 12
Waist circumference	Waist circumference at baseline and month 12 will be provided	Baseline, month 12
Number of patients smoking	Number of patients smoking at Baseline and at Month 12	Baseline, month 12
Number of cigarettes smoked per week	Number of cigarettes smoked per week at Baseline and at Month 12	Baseline, month 12
percentage of patients that have ceased smoking by Month 12	percentage of patients that have ceased smoking by Month 12 after the event.	Month 12
Percentage of patients that have changed their diet according to the recommendations	Percentage of patients that have changed their diet according to the recommendations (such as increasing consumption of vegetables, fruits, whole grains, fish; reducing intake of trans-fats, sweets, sugar-added beverages and red meat) by Month 12 after the event.	month 12
Average number of units of alcohol consumed daily	Average number of units of alcohol consumed daily at Baseline and at Month 12	Baseline, month 12
Percentage of patients that have decreased their alcohol intake	Percentage of patients that have decreased their alcohol intake by Month 12 after the event.	month 12
Average estimated time spent by physical activities per week	Average estimated time spent by physical activities per week	Baseline, month 12
Average number of steps walked daily	average number of steps walked daily at Baseline and Month 12.	Baseline, month 12
Percentage of patients that have increased their physical activity	Percentage of patients that have increased their physical activity by Month 12 after the event.	12 months
Percentage of patients who registered at a cardiologist during the study	Percentage of patients who registered at a cardiologist during the study	12 months
Percentage of patients adherent to statin therapy	Percentage of patients adherent to statin therapy at baseline and at Month 12 in both arms. Adherence is defined as taking medications as prescribed >75% of the time based on responses to Gehi et al. adherence question ("In the past month, how often did you take statins as the doctor prescribed?") on Month 12	Baseline, month 12
Number of participants by living conditions- family conditions	Living conditions- family conditions: marital status, number of children; place of residency (urban/rural)	Baseline
Lipid profile	Lipid profile (LDL-C, total cholesterol, HDL-C, VLDL-C, non-HDL-C and triglycerides).	Baseline, month 12
Lipid profile - Lp(a)	Lp(a) values at Baseline and month 12 will be provided	Baseline, month 12
Number of participants with comorbidities	Comorbidities (diabetes mellitus, chronic kidney disease) at Baseline	Baseline
Number of participants that manifest ASCVD in family history	Number of participants that manifest ASCVD in family history	Baseline
Number of participants by MI pharmacological treatment	Number of participants by Myocardial Infarction (MI) pharmacological treatment	12 months
Percentage of patients treated with PCSK9 antibodies to patients eligible for PCSK9 antibodies	Percentage of patients treated with PCSK9 antibodies to patients eligible for PCSK9 antibodies (according to the Czech reimbursement criteria).	12 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Link to study results

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): October 24, 2024
• Study Completion (Actual): October 24, 2024

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: myocardial infarction; LDL-C; secondary prevention; MI; Czech Republic; digital education
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction
• Other Study ID Numbers: CKJX839A1CZ01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO