Myocardial Infarction
Conditions
Keywords
myocardial infarction, MI, Czech Republic, secondary prevention, digital education, LDL-C
Brief 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.
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.
Interventions
OTHERsystematic 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.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in LDL-C levels from baseline at month 12 | Baseline, month 12 | Absolute change in LDL-C levels from baseline at month 12 after the event. |
| Relative (percentage) change in LDL-C levels from baseline at month 12 | Baseline, month 12 | Relative change in LDL-C levels from baseline at month 12 after the event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving their LDL-C target level | Month 12 | 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) |
| Change in total cholesterol from Baseline at Month 12 | Baseline, month 12 | Change in total cholesterol from Baseline at Month 12 |
| Change in HDL-C from Baseline at month 12 | Baseline, month 12 | Change in high-density lipoprotein cholesterol (HDL-C) |
| Change in VLDL-C from Baseline at month 12 | Baseline, month 12 | Change in very low- density lipoprotein cholesterol (VLDL-C). |
| Change in non-HDL-C from Baseline at month 12 | Baseline, month 12 | Change in non-high-density lipoprotein cholesterol (non-HDL-C). |
| Change in triglycerides from Baseline at month 12 | Baseline, month 12 | Change in triglycerides |
| Change in Lp(a) from Baseline at month 12 | Baseline, month 12 | Change in lipoprotein(a) \[Lp(a)\]) |
| Blood pressure | Baseline, month 12 | Blood pressure at baseline and month 12 will be provided |
| Body Mass Index | Baseline, month 12 | BMI (Body Mass Index) at baseline and month 12 will be provided |
| Waist circumference | Baseline, month 12 | Waist circumference at baseline and month 12 will be provided |
| Number of patients smoking | Baseline, month 12 | Number of patients smoking at Baseline and at Month 12 |
| Number of cigarettes smoked per week | Baseline, month 12 | Number of cigarettes smoked per week at Baseline and at Month 12 |
| percentage of patients that have ceased smoking by Month 12 | Month 12 | percentage of patients that have ceased smoking by Month 12 after the event. |
| Percentage of patients that have changed their diet according to the recommendations | month 12 | 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. |
| Average number of units of alcohol consumed daily | Baseline, month 12 | Average number of units of alcohol consumed daily at Baseline and at Month 12 |
| Percentage of patients that have decreased their alcohol intake | month 12 | Percentage of patients that have decreased their alcohol intake by Month 12 after the event. |
| Average estimated time spent by physical activities per week | Baseline, month 12 | Average estimated time spent by physical activities per week |
| Average number of steps walked daily | Baseline, month 12 | average number of steps walked daily at Baseline and Month 12. |
| Percentage of patients that have increased their physical activity | 12 months | Percentage of patients that have increased their physical activity by Month 12 after the event. |
| Percentage of patients who registered at a cardiologist during the study | 12 months | Percentage of patients who registered at a cardiologist during the study |
| Percentage of patients adherent to statin therapy | Baseline, month 12 | 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 |
| Number of participants by living conditions- family conditions | Baseline | Living conditions- family conditions: marital status, number of children; place of residency (urban/rural) |
| Lipid profile | Baseline, month 12 | Lipid profile (LDL-C, total cholesterol, HDL-C, VLDL-C, non-HDL-C and triglycerides). |
| Lipid profile - Lp(a) | Baseline, month 12 | Lp(a) values at Baseline and month 12 will be provided |
| Number of participants with comorbidities | Baseline | Comorbidities (diabetes mellitus, chronic kidney disease) at Baseline |
| Number of participants that manifest ASCVD in family history | Baseline | Number of participants that manifest ASCVD in family history |
| Number of participants by MI pharmacological treatment | 12 months | Number of participants by Myocardial Infarction (MI) pharmacological treatment |
| Percentage of patients treated with PCSK9 antibodies to patients eligible for PCSK9 antibodies | 12 months | Percentage of patients treated with PCSK9 antibodies to patients eligible for PCSK9 antibodies (according to the Czech reimbursement criteria). |
Countries
Czechia
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed