NCT01186445已完成3 期
Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction
French Cardiology Society2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Infarct size evaluated by delayed enhancement-magnetic resonance imaging
研究概览
简要总结
The purpose of this study is to determine whether intracoronary injection of morphine chlorhydrate is effective to limit ischemia-reperfusion lesion during percutaneous coronary angioplasty in patients with acute myocardial infarction (AMI).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Myocardial Infarction less than 6 hours defined by
- •prolonged chest pain (>15 min)
- •in association with
- •ST elevation 1mm or more in two contiguous leads
- •or occurence of Q wave in three contiguous leads
- •or occurence of left bundle branch block
- •Culprit lesion eligible for percutaneous coronary intervention (PCI)
- •TIMI flow 0 before PCI
排除标准
- •Fibrinolysis
- •Allergy to morphine
- •Active epilepsy
- •Brain injury or intracranial hypertension
- •Previous AMI, coronary artery bypass graft (CABG)
- •Cardiac arrest
- •Cardiogenic shock, significant mitral regurgitation or intraventricular communication at inclusion
- •Mechanical ventilation at inclusion
- •Significant ventricular arrhythmia or atrioventricular block type II or III at inclusion
- •Decompensated chronic obstructive pulmonary disease at inclusion
- •chronic hepatocellular failure
- •MRI contraindications
- •Gadolinium chelates injection contraindications
- •Current treatment with morphine chlorhydrate, buprenorphine, nalbuphine, pentazocine
研究组 & 干预措施
Morphine chlorhydrate
Experimental
Intracoronary injection of morphine chlorhydrate during reperfusion
干预措施: morphine chlorhydrate (Drug)
Saline solution
Placebo Comparator
Intracoronary injection of saline solution during reperfusion
干预措施: saline solution (Drug)
结局指标
主要结局
Infarct size evaluated by delayed enhancement-magnetic resonance imaging
时间窗: between day 3 and day 5 after acute myocardial infarction (AMI)
次要结局
- Infarct size measurement by delayed enhancement-magnetic resonance imaging(1 year)
- release of creatine kinase (CK) and troponin I (TnI) during reperfusion(during the first 72 hours after reperfusion)
- the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion(at day 0)
- ST segment resolution after reperfusion(during the first 24 hours after reperfusion)
- Left Ventricular Ejection Fraction measured by echocardiography(at day 1 and day 6)
- Infarct size/area at risk ratio evaluated by MRI(between day 3 and day 5 after AMI)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
3 期
Effect of intra coronary morphine in STEMIAcute myocardial infarction with ST elevation.ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarctionIRCT20220814055685N1Ghoum University of Medical Sciences110
终止
不适用
Intra-coronary Versus Intramyocardial Application of Enriched CD133pos Autologous Bone Marrow Derived Stem CellsHeart FailureNCT01337011Asklepios proresearch10
已完成
2 期
Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)Single Right VentricleSingle Left VentricleHypoplastic Left Heart SyndromeNCT01829750Okayama University34
已完成
4 期
Intra-articular Morphine and Clonidine Injections for Pain Management in Hip ArthroscopyFemoracetabular ImpingementPain, PostoperativeNCT02530151Northwestern University70
Unknown
不适用
Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic StenosisAortic Valve StenoisNCT03341169Yonsei University108