A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients
- Conditions
- Myocardial Infarction
- Interventions
- Other: systematic educational intervention
- Registration Number
- NCT06548555
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Participants eligible for inclusion in this study must fulfil all the following criteria:
-
Male or female patients ≥18 years of age,
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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,
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LDL-C ≥ 1.8 mmol/L at the time of the hospitalization,
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Ability to participate in the hybrid educational program (must be able to receive emails and watch online educational videos),
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Patients must provide written consent to participate in the study.
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Interventional arm systematic educational intervention Patients receiving the systematic educational intervention
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method Number of cigarettes smoked per week Baseline, month 12 Number of cigarettes smoked per week at Baseline and at Month 12
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
Waist circumference Baseline, month 12 Waist circumference at baseline and month 12 will be provided
Average estimated time spent by physical activities per week Baseline, month 12 Average estimated time spent by physical activities per week
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
Body Mass Index Baseline, month 12 BMI (Body Mass Index) 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
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.
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 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).
Change in HDL-C from Baseline at month 12 Baseline, month 12 Change in high-density lipoprotein cholesterol (HDL-C)
Change in non-HDL-C from Baseline at month 12 Baseline, month 12 Change in non-high-density lipoprotein cholesterol (non-HDL-C).
Number of participants by MI pharmacological treatment 12 months Number of participants by Myocardial Infarction (MI) pharmacological treatment
Change in VLDL-C from Baseline at month 12 Baseline, month 12 Change in very low- density lipoprotein cholesterol (VLDL-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
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.
Number of participants by living conditions- family conditions Baseline Living conditions- family conditions: marital status, number of children; place of residency (urban/rural)
Number of participants with comorbidities Baseline Comorbidities (diabetes mellitus, chronic kidney disease) at Baseline
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.
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.
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 that manifest ASCVD in family history Baseline Number of participants that manifest ASCVD in family history
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇿Praha, Czechia