Germany on Target Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 主要终点
- LDL-C target attainment
研究概览
简要总结
Germany on Target Registry (DaZiR) is a prospective, Germany-wide patient registry designed to assess lipid management and low-density lipoprotein cholesterol ( LDL-C) target attainment in adults following acute myocardial infarction (STEMI or NSTEMI).
Eligible patients are informed about the registry by treating physicians or their medical teams and receive an individual access link or QR code. Following electronic informed consent and registration, participants provide clinical and follow-up information through the brite™ platform.
Clinical data, including LDL-C values and lipid-lowering treatment, can be entered by the participants or obtained from uploaded medical documents. The platform enables participants to follow the course of their LDL-C values and provides reminders for scheduled follow-up data collection.
Medical treatment is determined independently by the treating physicians as part of routine clinical care and is not assigned by the registry. The registry aims to assess LDL-C target attainment over time, changes in lipid-lowering treatment, treatment adherence and cardiovascular outcomes following myocardial infarction.
详细描述
Germany on Target Registry is a prospective patient registry investigating lipid management and cardiovascular secondary prevention following acute myocardial infarction in Germany.
Adults following ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) may be informed about the registry by participating physicians and medical institutions. The role of the physicians is primarily limited to identifying potentially eligible patients, providing information about the registry and supplying an individual access link or QR code.
Following registration and electronic informed consent, further study participation is conducted through the Brite™ digital platform provided by XO Life. Participants provide follow-up information directly through the platform. Relevant laboratory values can be entered manually or obtained from medical documents uploaded by the participant.
Baseline information includes characteristics of the index myocardial infarction, LDL-C values at admission and/or discharge, lipid-lowering treatment and relevant cardiovascular risk factors and laboratory parameters. Follow-up assessments document LDL-C values, changes in lipid-lowering therapy and additional clinical information.
The primary focus of the registry is the proportion of participants achieving the predefined LDL-C target of <55 mg/dL and the maintenance of LDL-C target attainment during follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosis of acute ST-elevation myocardial infarction (STEMI) or non-ST- elevation myocardial infarction (NSTEMI)
- •Provision of informed consent for participation in the registry
排除标准
- •No informed consent for participation in the registry
研究组 & 干预措施
Patients following acute myocardial infarction
Adults following an acute ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) who voluntarily enroll in the Deutschland auf Ziel registry and are prospectively followed through the brite™ platform.
干预措施: No study-assigned intervention (Other)
结局指标
主要结局
LDL-C target attainment
时间窗: 12 months
The primary endpoint of the study/registry is the achievement and maintenance of the LDL-C target level recommended by the current ESC/EAS guidelines for high-risk cardiovascular patients during the follow-up period. Assessment is based on documented LDL-C measurements taken at specified time points (after 6 weeks, 3, 6, and 12 months, as well as during the subsequent long-term follow-up).
次要结局
- Absolute change in LDL cholesterol(Baseline to 60 month)
- Percentage change in LDL cholesterol(Baseline to 60 Month)
- Body weight(Baseline)
- Body height(Baseline)
- Body mass index(Baseline)
- HDL cholesterol concentration(Baseline to 60 month)
- Triglyceride concentration(Baseline to 60 mionth)
- Lipoprotein(a) concentration(Baseline)
- HbA1c(Baseline to 60 month)
- hsCRP(Baseline to 60 month)
- Blood pressure(Baseline)
- Changes in lipid-lowering therapy during follow-up(Baseline to 60 month)
- Proportion of participants with documented intensification of lipid-lowering therapy(Baseline to 60 month)
- Participant-reported adherence to prescribed lipid-lowering therapy(Baseline to 60 month)
- Occurrence of cardiovascular events during follow-up(Baseline to 60 month)