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临床试验/EUCTR2011-000911-26-DE
EUCTR2011-000911-26-DE进行中(未招募)不适用

Heart rate control after acute myocardial infarct - STEMI

niversity of Cologne0 个研究点开始时间: 2011年4月13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)
发起方

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

  • Acute st-segment elevation myocardial infarction (time between symptom onset and PCI < 6 hours) with successful PCI (TIMI III°)
  • Killip Klassification I, II
  • Written informed consent
  • Resting heart rate = 60 bpm
  • Age above 18 years
  • Mean blood pressure = 65 mmHg
  • Systolic blood pressure > 90mmHg
  • Medication with Heparin (weight adapted), clopidogrel ans aspirin before PCI
  • SO2 > 90%
  • Elevated heart rate (= 60/min)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 50

排除标准

  • Mean blood pressure < 65 mmHg
  • Incomplete PCI success (TIMI < III)
  • Cardiogenic shock
  • Killip Klassification III, IV
  • Symptomatic AV conduction block II°, III°
  • Catecholamin therapy
  • Heart rate < 60/min.
  • Severe peripheral artery disease (Fontaine > IIb)
  • Moderate to severe renal impairment (Serum-creatinin > 2 mg/100ml)
  • Severe liver dysfunction
  • Severe acidosis (pH < 7,2)
  • Known contraindications for Brevibloc (e.g. asthma bronchiale) or known intolerance to Brevibloc
  • Participation in other interventional studies
  • Person related to the sponsor or investigator
  • Unterbringung in einer Anstalt aufgrund gerichtlicher oder behördlicher Anordnung
  • Subjects who were not eligible for follow-up visits (e.g. due to long distance between study hospital and home adress)
  • Women in whom a pregnancy cannot excluded
  • Missing safe contraception (hormonal or copper spirale)
  • Patients without guidelines recommended therapy previosly to PCI
  • Patients in whom anamnestic the symptom onset was > 6 hours or first laboratory tests indicate (LDH > 280U/I) that the myocardial infarction onset was more than 6 hours and in whom no other reasons for elevated LDH are present.
  • Unsuccessful PCI
  • Symptom onset > 6 hours

研究者

发起方
niversity of Cologne

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