EUCTR2009-011485-28-SE进行中（未招募）不适用
A local feasibility study of mangafodipir as an adjunct to percutaneous coronary intervention in patients with acute myocardial infarction - MANAMI PP01-99
PledPharma AB0 个研究点开始时间: 2009年6月16日最近更新:
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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
- •a. Males 40-80 years and females 50-80 years with AMI ( acute myocardial infarction)
- •b. Chest pain up to 6 hours.
- •c. ST segment elevation in two neighbouring leads in the anterior wall (= 0.2 mV) or in the inferior wall (= 0.1 mV) of the left ventricle.
- •d. Decided for treatment by primary PCI.
- •e. TIMI grade 0 flow in the occluded LAD/RCA artery
- •f. Written 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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •a. Previous coronary artery bypass operation.
- •b. Previous AMI.
- •c. Chest pain more than 6 hours.
- •d. Angina within 48 hours before admission.
- •e. Cardiac arrest and cardiogenic shock.
- •f. Occlusion of other coronary arteries than LAD.
- •g. Known hypersensitivity to mangafodipir (as contrast agent for MRI).
- •h. Received mangafodipir = 5 weeks before admission
- •i. History of prior serious allergic or pseudo-allergic reaction
- •j. Severely reduced liver or renal function
- •k. Any other serious illness or medical condition
- •l. Fertile females
- •m. Phaeochromocytoma
- •n. Thrombolytic treatment applied before primary PCI
研究者
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