DRKS00033905尚未招募Unknown
Prognostic impact of COronary Angiography in patients with acute ischemic Stroke and Troponin elevation - COAST-trial
niversität Heidelberg0 个研究点目标入组 540 人开始时间: 2024年6月7日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 540
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 90 Years(—)
- 性别
- All
入选标准
- •[1] Written informed consent obtained from the patient or their guardian or written indication by the attending physician.
- •[2] Age 40-90 years.
- •[3] Acute ischemic stroke with clinical and morphologic signs in the past 72 hours.
- •[4] Increase in absolute troponin values depending on the troponin tests available in the respective study center according to the current ACS guidelines. This means either highly sensitive troponin assays (hs-cTN) or conventional cTN assays with an increase and/or decrease above the 99th percentile of a healthy reference population (4th universal myocardial infarction definition).
- •[5] One of these criteria must be met:
- •- At least 3 cardiovascular risk factors from
- •o Obesity (BMI >30kg/m2)
- •o Arterial hypertension (treated with medication)
- •o Diabetes mellitus (treated with medication or diet)
- •o Dyslipoproteinemia (LDL >150mg/dl or drug therapy)
- •o Harmful use of tobacco (active smoking)
- •o familial disposition for CHD
- •- Increase in high-sensitivity troponin to = 5 times the upper norm
- •- Previously known/intervened obstructive or non-obstructive coronary heart disease with at least 50% stenosis in at least one coronary vessel
排除标准
- •[1] Invasive exclusion of coronary heart disease (CHD) in the previous 12 months.
- •[2] Acute ST-segment myocardial infarction (STEMI), according to European ACS guideline (Byrne 2023 EHJ), New ST elevation at the J-point in at least two contiguous leads: - =2.5 mm in men =2mm in men =40 years, or =1.5 mm in women regardless of age in leads V2-V3 and/or =1 mm in the other leads (in the absence of left ventricular [LV] hypertrophy or left bundle branch block [LBBB]) documented in all uptake 12-lead ECGs plus at the time of study inclusion.
- •[3] History of grade III valvular heart disease.
- •[4] Current endocarditis.
- •[5] GOLD E stage COPD and/or COPD requiring long-term oxygenation.
- •[6] Pregnancy or breastfeeding.
- •[7] Absolute contraindications for CA (e.g. hemorrhagic infarction, defined as parenchymal hematoma (PH) 1 and PH 2 according to Fiorelli (1999), planned urgent surgery with absolute contraindication.
- •[8] Persistent platelet count < 50,000/µl at index hospitalization.
- •[9] Severe acute infection, defined as C-reactive protein >100 g/dl and/or leukocytosis >15,000/µl in combination with a clinical focus of infection.
- •[10] Sepsis and septic shock according to the Sepsis 3 criteria.
- •[11] Malignancy or comorbidity with a life expectancy of =12 months.
研究者
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