Cholesterol Self-testing in Patients Post Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- percentage value LDL-Cholesterol reduction in comparison to baseline
研究概览
简要总结
The pharmacological reduction of LDL-C lowers cardiovascular risk and is therefore a priority in cardiovascular secondary prevention. The achievement of LDL-C target levels in Germany, Europe, and worldwide is inadequate, despite a wide array of lipid-lowering medications. Only a small proportion of post-myocardial infarction patients reach their LDL-C target range within a year. There is a significant need for new strategies to improve LDL-C target achievement and thereby reduce the occurrence of secondary cardiovascular events.
The aim of the study is to establish a basis for improving prevention by achieving the target LDL level effectively and quickly in patients with high and very high cardiovascular risk profiles.
详细描述
In this randomized study, the investigators aim to investigate whether additional self-monitoring of cholesterol values by patients leads to more effective LDL reduction and quicker achievement of the target LDL range versus usual care.
This study systematically and prospectively examines the benefits of self-monitoring and control of cholesterol levels for the first time.
The patients in the intervention arm will receive a device for self-measurement of cholesterol values and will be trained in its use. These patients will independently measure their cholesterol levels monthly using capillary blood tests and report the results to the study physicians, who will then adjust the therapy accordingly. The control arm is treated according to local standards, which includes control of the cholesterol values twice a year at the visit in out-patient clinic. Patients in both study arms will be followed up for at least 12 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients with acute coronary syndrome in the last 6 months and not having reached the LDL target value
- •Signed informed consent
排除标准
- •Persons unable to understand the study
- •Persons unable or unwilling to perform self-measurements
- •Persons unable or unwilling to undergo additional cholesterol-lowering therapy to reach the LDL target
- •Pre-menopausal women without contraception
- •Use of experimental drugs or investigational products within 30 days prior to screening
- •Employees or contractors of the institution conducting the study or family members of the Principal Investigator, Co-Investigator, or financial supporter
结局指标
主要结局
percentage value LDL-Cholesterol reduction in comparison to baseline
时间窗: 6 months
Compare the change in value of LDL-Cholesterol with additional monthly self measurement of parameters after 6 months versus baseline and the control group.
次要结局
未报告次要终点