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Myocardial InfarctionDEDUCA-CZNCT06548555

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

An observational study of Myocardial Infarction, run by Novartis Pharmaceuticals at 5 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Myocardial Infarction
What is being tested?
systematic educational intervention
How many people
121 participants
Where
5 sitesCzechia
Study dates
8 Mar 2023to 24 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients after the first myocardial infarction.

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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,
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  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

Czechia5 sites

  • Novartis Investigative Site

    Brno-Bohunice, 625 00

  • Novartis Investigative Site

    České Budějovice, 370 01

  • Novartis Investigative Site

    Ostrava Poruba, 708 52

  • Novartis Investigative Site

    Prague, 12808

  • Novartis Investigative Site

    Prague, 150 30

Other trials in Czechia

About this study

Official title: 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.

Read the 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.

Being tested
systematic educational intervention
Keywords
myocardial infarction, MI, Czech Republic, secondary prevention, digital education, LDL-C
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • systematic educational interventionOther

    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.

Study groups in NCT06548555
Study groupRoleWhat they receive
Interventional armPatients received the systematic educational intervention
Receives: Other: systematic educational intervention
Control armPatients treated in the clinical routine mode (the education of the patient follows routine practice and no added education is provided by the Healthcare Professionals).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, month 12

  2. 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.

    Measured: Baseline, month 12

Secondary outcomes (28)

  1. 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)

    Measured: Month 12

  2. Change in total cholesterol from Baseline at Month 12

    Change in total cholesterol from Baseline at Month 12

    Measured: Baseline, month 12

  3. Change in HDL-C from Baseline at month 12

    Change in high-density lipoprotein cholesterol (HDL-C)

    Measured: Baseline, month 12

  4. Change in VLDL-C from Baseline at month 12

    Change in very low- density lipoprotein cholesterol (VLDL-C).

    Measured: Baseline, month 12

  5. Change in non-HDL-C from Baseline at month 12

    Change in non-high-density lipoprotein cholesterol (non-HDL-C).

    Measured: Baseline, month 12

  6. Change in triglycerides from Baseline at month 12

    Change in triglycerides

    Measured: Baseline, month 12

  7. Change in Lp(a) from Baseline at month 12

    Change in lipoprotein(a) [Lp(a)])

    Measured: Baseline, month 12

  8. Blood pressure

    Blood pressure at baseline and month 12 will be provided

    Measured: Baseline, month 12

  9. Body Mass Index

    BMI (Body Mass Index) at baseline and month 12 will be provided

    Measured: Baseline, month 12

  10. Waist circumference

    Waist circumference at baseline and month 12 will be provided

    Measured: Baseline, month 12

  11. Number of patients smoking

    Number of patients smoking at Baseline and at Month 12

    Measured: Baseline, month 12

  12. Number of cigarettes smoked per week

    Number of cigarettes smoked per week at Baseline and at Month 12

    Measured: Baseline, month 12

  13. percentage of patients that have ceased smoking by Month 12

    percentage of patients that have ceased smoking by Month 12 after the event.

    Measured: Month 12

  14. 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.

    Measured: month 12

  15. Average number of units of alcohol consumed daily

    Average number of units of alcohol consumed daily at Baseline and at Month 12

    Measured: Baseline, month 12

  16. Percentage of patients that have decreased their alcohol intake

    Percentage of patients that have decreased their alcohol intake by Month 12 after the event.

    Measured: month 12

  17. Average estimated time spent by physical activities per week

    Average estimated time spent by physical activities per week

    Measured: Baseline, month 12

  18. Average number of steps walked daily

    average number of steps walked daily at Baseline and Month 12.

    Measured: Baseline, month 12

  19. Percentage of patients that have increased their physical activity

    Percentage of patients that have increased their physical activity by Month 12 after the event.

    Measured: 12 months

  20. Percentage of patients who registered at a cardiologist during the study

    Percentage of patients who registered at a cardiologist during the study

    Measured: 12 months

  21. 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

    Measured: Baseline, month 12

  22. Number of participants by living conditions- family conditions

    Living conditions- family conditions: marital status, number of children; place of residency (urban/rural)

    Measured: Baseline

  23. Lipid profile

    Lipid profile (LDL-C, total cholesterol, HDL-C, VLDL-C, non-HDL-C and triglycerides).

    Measured: Baseline, month 12

  24. Lipid profile - Lp(a)

    Lp(a) values at Baseline and month 12 will be provided

    Measured: Baseline, month 12

  25. Number of participants with comorbidities

    Comorbidities (diabetes mellitus, chronic kidney disease) at Baseline

    Measured: Baseline

  26. Number of participants that manifest ASCVD in family history

    Number of participants that manifest ASCVD in family history

    Measured: Baseline

  27. Number of participants by MI pharmacological treatment

    Number of participants by Myocardial Infarction (MI) pharmacological treatment

    Measured: 12 months

  28. 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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start8 Mar 2023
  3. Primary completion24 Oct 2024
  4. Study completion24 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06548555
Sponsor's protocol ID
CKJX839A1CZ01
Acronym
DEDUCA-CZ
Status last verified
Oct 2025
First submitted
7 Aug 2024
Last updated
4 Jun 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by Novartis Pharmaceuticals at 5 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change in LDL-C levels from baseline at month 12 (time frame: Baseline, month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06548555.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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