PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 28
- 主要终点
- Presence of Myocardial Infarction
研究概览
简要总结
The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients with elevated levels of cardiac troponin.
详细描述
Elevation of cardiac troponin can be found in about 30% of patients with acute ischemic stroke (depending on the assay used). Elevated troponin indicates increased mortality in stroke patients. There is currently little evidence regarding the ideal care of these patients. The investigators know from previous studies that approximately 25% of acute stroke patients with elevated levels of cardiac troponin have culprit lesions on coronary angiogram.
The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients. To achieve this, clinical symptoms, troponin levels as well as findings on EKG, echocardiography and coronary angiography will be systematically evaluated. The PRAISE study is a multicenter study with more than 20 sites in Germany. Joint funding will be provided by DZHK (German center of cardiovascular research) und DZNE (German center of neurodegenerative diseases). Acute ischaemic stroke patients with elevated troponin are eligible for participation in the study. The primary endpoint is the diagnosis of acute coronary syndrome as established by an independent endpoint committee.
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
- •diagnosis of ischemic stroke based on clinical and imaging information (CT or MRI)
- •diagnosis of transient ischemic attack if the initial focal neurological deficit has been examined by a neurologist and if the ABCD2-score is ≥ 4
- •Elevation of high-sensitive cardiac troponins according to the rule-in/rule-out algorithm of the 2015 ESC guidelines for NSTE-ACS, i.e. highly abnormal troponin at 0 hours (> 52ng/l if hs-cTnT, Elecsys-Assay, or > 52ng/l, if hs-cTnI; Architect-Assay, or > 107 ng/l, if hs-cTnI. Dimension Vista Assay) or dynamic change > 20% of the initial value at re-test after 3 hours with at least one value above the 99th percentile of a healthy reference population
- •ability to give informed consent
- •onset of symptoms < 72 hours prior to hospital admission
排除标准
- •renal insufficiency (GFR < 30 ml/min/m²)
- •contraindications for coronary angiography (e.g. manifest hyperthyroidism, allergy to contrast agent)
- •lesion size > 100 ml (either on Diffusion Weighted Imaging on cMRI or on CT if CT is performed > 24 hours after onset) or ASPECTS score < 7 (on CT if CT is performed < 24 hours after onset)
- •Premorbid degree of dependence (mRS > 3)
- •pregnancy or breast-feeding
- •limited life expectancy < 1 year
- •consent to participate in the study given > 72 hours after hospital admission
结局指标
主要结局
Presence of Myocardial Infarction
时间窗: within seven days of admission to hospital
the diagnosis will be established by an independent endpoint committee
次要结局
- Mortality(at one week and at three and twelve months after the initial event, at 12 months reported.)
- Functional Outcome(at baseline, at one week and at three and twelve months after the initial event, 12 months reported)
- Cardiovascular Events(at one week and at three and twelve months after the initial event, 12 months reported)
研究者
Matthias Endres
Prof Dr med. Matthias Endres
Charite University, Berlin, Germany