Mangafodipir as an Adjunct to Percutaneous Coronary Intervention in Acute Myocardial Infarction (MANAMI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction of myocardial infarct size assessed by biomarker release to plasma
研究概览
简要总结
The present feasibility study is designed to find out whether pre-treatment with the compound mangafodipir (PP-099) provides an additional reduction in myocardial infarct size in patients treated with primary percutaneous coronary intervention (PCI) during acute myocardial infarction (AMI).
详细描述
Mangafodipir, manganese (Mn) dipyridoxyl diphosphate (MnDPDP) and its lipophile metabolite Mn dipyridoxyl diethylene diamide (MnPLED), are catalytic antioxidants and iron chelators. In preclinical studies these agents reduce oxidative stress induced injuries related to chemotherapy of cancer and to reperfusion/reoxygenation of ischemic/hypoxic myocardium. Accordingly, in an in vivo pig model of AMI metabolite MnPLED applied at end of ischemia and during reperfusion reduced myocardial infarct size by 55 %. Mangafodipir most likely activates salvage pathways and prevents lethal reperfusion injuries.
Other advantages are that mangafodipir is already approved as a contrast agent for MRI of liver, and that the experience for more than a decade reveals a high safety with minor and tolerable side-effects.
The present study will include 20 patients treated for their first documented AMI. They will after admission to hospital undergo primary PCI. Reopening of an occluded coronary artery will be preceded by iv. infusion of mangafodipir or placebo in two groups , each consisting of 10 patients. The primary endpoint will be release to plasma of commonly accepted biomarkers of myocardial injury (Troponin T and CK-MB) measured at admission and 6 hours after PCI. The secondary endpoints include the accumulated release of plasma biomarkers over 48 hours and direct measurement of the final myocardial infarct size at 6-10 weeks after PCI.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males 40-80 and females 50-80 years with first severe coronary attack
- •Chest pain up to 6 hours.
- •T segment elevation (≥ 0.2 mV in two neighbouring anterior and inferior wall leads.
- •Decided for treatment by primary PCI.
- •TIMI grade 0 flow in the occluded LAD or RCA artery
- •Written informed consent.
排除标准
- •Previous coronary artery bypass operation.
- •Previous AMI.
- •Chest pain more than 6 hours.
- •Angina within 48 hours before admission.
- •Cardiac arrest and cardiogenic shock.
- •Occlusion of the left main stem, circumflex and right coronary arteries at angiography.
- •Known hypersensitivity to mangafodipir (as contrast agent for MRI).
- •Received mangafodipir ≤ 5 weeks before admission
- •History of prior serious allergic or pseudo-allergic reaction
- •Severely reduced liver or renal function
- •Any other serious illness or medical condition
- •Fertile females
- •Phaeochromocytoma
研究组 & 干预措施
Mangafodipir treatment
Treatment will be undertaken with a ready-to use investigative drug formulation identical to what is in diagnostic use as a contrast medium for MRI. Formulation content: MnDPDP 10 mmol/ml.
干预措施: Mangafodipir (Drug)
NaCl 0.9%
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction of myocardial infarct size assessed by biomarker release to plasma
时间窗: Before and at 2 days after PCI
次要结局
- Reduction of myocardial infarct size assessed by biomarker release to plasma and by magnetic resonance imaging (MRI) of the heart.(Accumulated biomarker release over 48 hours after PCI; MRI at 6-10 weeks after PCI.)