EUCTR2006-001767-31-GB进行中(未招募)1 期
Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes - MRC-ILA-HEART study
niversity of Sheffield0 个研究点目标入组 186 人开始时间: 2008年2月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 186
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
入选标准
- •1) Acute severe cardiac chest pain consistent with an acute coronary syndrome
- •2) <48 hours from onset of symptoms that led to hospital admission
- •And at least one of the following:
- •i) Horizontal or down-sloping ST depression of at least 0.5mm in at least 2 ECG leads
- •ii) A raised troponin as defined by local parameters specified at each centre
- •iii) Other ECG changes consistent with acute myocardial ischaemia (e.g.T-wave inversion of at least 3mm, in at least two leads of the ECG, or new onset bundle branch block) and an elevated level of Troponin above local laboratory values indicating myocardial damage
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) < 18 years of age
- •2) Persistent ST elevation on the presenting ECG
- •3) Intention to treat with an urgent reperfusion strategy (thrombolysis or primary percutaneous coronary intervention)
- •4) Percutaneous coronary intervention within previous 3 months
- •5) Previous coronary artery bypass grafting
- •6) ECG showing paced rhythm
- •7) Cardiogenic shock
- •8) Any serious co-morbidity which makes it unlikely that the patient will complete trial procedures and follow-up
- •9) Treatment or under active follow-up for rheumatoid arthritis, other connective tissue diseases or inflammatory bowel disease
- •10) End stage renal disease or a Creatinine > 220µmol/L
- •11) Pregnancy or suspected pregnancy (any potential female participant of child bearing age will need a negative pregnancy test prior to study entry)
- •12) Eosinophilia
- •13) anti-TNF biologies
- •14) Active infection
- •15) Malignancy
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