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临床试验/DRKS00033905
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

发起方
niversität Heidelberg

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