Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: myocardial infarction
MI
Czech Republic
secondary prevention
digital education
LDL-C
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients after the first myocardial infarction.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Absolute change in LDL-C levels from baseline at month 12
timeFrame: Baseline, month 12
measure: Relative (percentage) change in LDL-C levels from baseline at month 12
timeFrame: Baseline, month 12
Secondary outcomes:
measure: Percentage of patients achieving their LDL-C target level
timeFrame: Month 12
measure: Change in total cholesterol from Baseline at Month 12
timeFrame: Baseline, month 12
measure: Change in HDL-C from Baseline at month 12
timeFrame: Baseline, month 12
measure: Change in VLDL-C from Baseline at month 12
timeFrame: Baseline, month 12
measure: Change in non-HDL-C from Baseline at month 12
timeFrame: Baseline, month 12
measure: Change in triglycerides from Baseline at month 12
timeFrame: Baseline, month 12
measure: Change in Lp(a) from Baseline at month 12
timeFrame: Baseline, month 12
measure: Blood pressure
timeFrame: Baseline, month 12
measure: Body Mass Index
timeFrame: Baseline, month 12
measure: Waist circumference
timeFrame: Baseline, month 12
measure: Number of patients smoking
timeFrame: Baseline, month 12
measure: Number of cigarettes smoked per week
timeFrame: Baseline, month 12
measure: percentage of patients that have ceased smoking by Month 12
timeFrame: Month 12
measure: Percentage of patients that have changed their diet according to the recommendations
timeFrame: month 12
measure: Average number of units of alcohol consumed daily
timeFrame: Baseline, month 12
measure: Percentage of patients that have decreased their alcohol intake
timeFrame: month 12
measure: Average estimated time spent by physical activities per week
timeFrame: Baseline, month 12
measure: Average number of steps walked daily
timeFrame: Baseline, month 12
measure: Percentage of patients that have increased their physical activity
timeFrame: 12 months
measure: Percentage of patients who registered at a cardiologist during the study
timeFrame: 12 months
measure: Percentage of patients adherent to statin therapy
timeFrame: Baseline, month 12
measure: Number of participants by living conditions- family conditions
timeFrame: Baseline
measure: Lipid profile
timeFrame: Baseline, month 12
measure: Lipid profile - Lp(a)
timeFrame: Baseline, month 12
measure: Number of participants with comorbidities
timeFrame: Baseline
measure: Number of participants that manifest ASCVD in family history
timeFrame: Baseline
measure: Number of participants by MI pharmacological treatment
timeFrame: 12 months
measure: Percentage of patients treated with PCSK9 antibodies to patients eligible for PCSK9 antibodies
timeFrame: 12 months
Other outcomes:
Locations:
city: Brno Bohunice
country: Czechia
facility: Novartis Investigative Site
city: Ceske Budejovice
country: Czechia
facility: Novartis Investigative Site
city: Ostrava Poruba
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: