NCT02122484已完成4 期
Study of Anti-inflammatory Treatment With Colchicine in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery to Reduce Reperfusion Damage
G.Gennimatas General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Myocardial damage marker levels
研究概览
简要总结
There is evidence that inflammatory processes may play a key role during surgical myocardial reperfusion. The hypothesis of this study is that colchicine, an anti-inflammatory agent, may lead to reduction in periprocedural infarct size, when administered during elective coronary artery bypass graft surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will enroll patients 18 years old or older who are eligible to undergo CABG surgery.
排除标准
- •Excluded are patients:
- •with age > 80 years old
- •scheduled for concomitant valve surgery
- •scheduled for coronary surgery without cardiopulmonary bypass
- •with peripheral vascular disease affecting the upper limbs
- •with acute coronary syndrome within the previous 4 weeks
- •on inotropic or mechanical circulatory support before induction of anaesthesia
- •with any disorder that could potentially increase preoperative cTnI concentrations (eg, percutaneous coronary intervention within the previous 6 weeks)
- •with active inflammatory diseases, infectious diseases or known malignancy
- •under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
- •with known hypersensitivity-allergy to colchicine
- •under chronic treatment with colchicine
- •with severe renal failure (eGFR < 35 ml/min/1.73 m2)
- •with hepatic failure (Child - Pugh class B or C)
研究组 & 干预措施
Colchicine
Experimental
Active treatment group
干预措施: Colchicine (Drug)
结局指标
主要结局
Myocardial damage marker levels
时间窗: Days 1-2 post-CABG
次要结局
- All cause mortality(At one and at six months after CABG)
研究者
Spyridon Deftereos
Director, Cardiac Catheterization Department
G.Gennimatas General Hospital
研究点 (1)
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