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临床试验/EUCTR2014-005369-64-ES
EUCTR2014-005369-64-ES进行中(未招募)不适用

Improve the myocardial reperfusion in ST elevation myocardial infarction: a randomized study between standard percutaneous coronary intervention with thrombectomy and pharmacological approach guided by the angiographic evidence of thrombus - iBEAST

Consorci MAr Parc de Salut de Barcelona0 个研究点开始时间: 2015年3月27日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • -Chest pain suggestive of myocardial ischemia for at least 30 minutes
  • -Symptoms onset less than 12 hours before hospital admission
  • -ST segment elevation of at least 1 mm in two or more contiguous leads (>o = 2mm in precordial leads)
  • -To understand and accept the study procedures and signed informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 70

排除标准

  • -ST elevation myocardial infarction presenting with cardiogenic shock
  • -Previous myocardial infarction (< 6 months)
  • -Formal contraindication to thrombolysis or to prasugrel
  • -Patients on oral anticoagulation therapy
  • -Patients treated with vitamin K, bivalirudin or fondaparinux
  • -Patients with severe renal failure (glomerular filtration rate <30ml/min/m2)
  • -Patients with contraindication to study medications, which cannot be managed medically, including: adenosine, heparin, IIb-IIIa inhibitors, contrast agents, clopidogrel, ticagrelor, prasugrel or aspirin
  • -Known life-threatening disease with a life expectancy of <12 months
  • -Inability to obtain informed consent
  • -Patients with contraindications to cardiovascular magnetic resonance
  • -Pregnant or breastfeeding patient
  • -Allergic reaction to the product (Methylase) and/or excipient
  • -Patients presenting with pace rhytm, preexcitation or other conditions or artifacts interfering with the interpretation of ST segment resolution
  • -Patient presenting with second or third degree of atrioventricular block or need of temporal pacemarker
  • -Culprit lesion located in small segments or secundary branches <2.5 mm diameter
  • -Impossibility to advance thrombectomy/Amicath device due to extreme tortuosy or calcification
  • -Significant left main disease
  • -Thrombolysis in myocardial infarction (TIMI) flow 3 without the visualization of intracoronary thrombus at initial angiography

研究者

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Improve the myocardial reperfusion in ST elevation... | 临床试验