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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 6
- 主要终点
- Relative (percentage) change in LDL-C levels from baseline at month 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Relative (percentage) change in LDL-C levels from baseline at month 12
时间窗: 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
时间窗: Baseline, month 12
Absolute change in LDL-C levels from baseline at month 12 after the event.
次要结局
- Number of cigarettes smoked per week(Baseline, month 12)
- Percentage of patients achieving their LDL-C target level(Month 12)
- Change in total cholesterol from Baseline at Month 12(Baseline, month 12)
- Waist circumference(Baseline, month 12)
- Average estimated time spent by physical activities per week(Baseline, month 12)
- Percentage of patients adherent to statin therapy(Baseline, month 12)
- Body Mass Index(Baseline, month 12)
- Number of patients smoking(Baseline, month 12)
- Average number of units of alcohol consumed daily(Baseline, month 12)
- Percentage of patients that have decreased their alcohol intake(month 12)
- Percentage of patients who registered at a cardiologist during the study(12 months)
- Percentage of patients treated with PCSK9 antibodies to patients eligible for PCSK9 antibodies(12 months)
- Change in HDL-C from Baseline at month 12(Baseline, month 12)
- Change in non-HDL-C from Baseline at month 12(Baseline, month 12)
- Number of participants by MI pharmacological treatment(12 months)
- Change in VLDL-C from Baseline at month 12(Baseline, month 12)
- Change in triglycerides from Baseline at month 12(Baseline, month 12)
- Change in Lp(a) from Baseline at month 12(Baseline, month 12)
- Blood pressure(Baseline, month 12)
- Percentage of patients that have changed their diet according to the recommendations(month 12)
- Number of participants by living conditions- family conditions(Baseline)
- Number of participants with comorbidities(Baseline)
- percentage of patients that have ceased smoking by Month 12(Month 12)
- Average number of steps walked daily(Baseline, month 12)
- Percentage of patients that have increased their physical activity(12 months)
- Lipid profile(Baseline, month 12)
- Lipid profile - Lp(a)(Baseline, month 12)
- Number of participants that manifest ASCVD in family history(Baseline)