"Intensive Lipid-Lowering Therapy Guided by a Cloud-based Software System (CLIMEDO GmbH) in Patients With ST-Elevation and Non-ST-Elevation Myocardial Infarctions" (Germany on Target)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- LDL-C
研究概览
简要总结
Intensive Lipid-Lowering Therapy guided by a cloud-based Software System (CLIMEDO GmbH) improves (European Society of Cardiolofgy/European Atherosclerosis Society) ESC/EAS-guideline recommended LDL-cholesterol target attainment and adherence in patients with ST-Elevation Myocardial (STEMI) and Non-ST-Elevation Myocardial Infarctions (NSTEMI).
详细描述
Patients admitted to the Jena University Hospital (UKS) and 9 other University hospitals in Germany with an ST-elevation or Non-ST-elevation myocardial infarction (STEMI) will be randomized to standard care or a software-based tool (CLIMEDO GmbH) to monitor low-density cholesterol (LDL-C) levels and close follow-ups to achieve ESC/EAS-guideline recommended LDL-C goals.
In this multi-center, prospective, randomized, interventional trial we propose that using a cloud-based software system (CLIMEDO GmbH) is superior to standard care in terms of LDL-C target attainment at 6 months and adherence over a time period of 12 months.
In the software group LDL-C levels will be monitored on admission, after 1,6, 12, 16, 20 weeks and after 6, 12 and 24 months. In the standard care group patients' LDL-C levels will be determined on admission after 6, 12 and 24 months. The primary endpoint is LDL-C target attainment at 6 months in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with ST- and Non-ST-elevation myocardial infarctions
排除标准
- •patient without informed concent
- •patients in cardiogenic shock
- •patients with contraindication to lipid-lowering therapy
- •patients on lipid-lowering medications on admission
研究组 & 干预措施
Cloud-based software
cloud-based software system (CLIMEDO GmbH) will support patients in ESC/EAS LDL-C target attainment (< 55mg/dl/1.4 mol/L)
干预措施: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran (Drug)
Standard Care
Patients will be treated by general practitioners (GPs) after hospital discharge. The discharge letter will recommend ESC/EAS dyslipidemia LDL-cholesterol targets (< 55mg/dl/1.4 mol/L)
干预措施: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran (Drug)
结局指标
主要结局
LDL-C
时间窗: 6 months
LDL-C target attainment (ESC/EAS dyslipidemia guidelines)
次要结局
- side-effects of lipid lowering therapy(6 months)
- adherence to LLT(12 months)