Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 18
- 主要终点
- multiorgan failure evaluated by the SOFA score
研究概览
简要总结
The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced by tissue reperfusion. These reperfusion's injuries can be reduced by injection of cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock improves short-term and long term survival by reducing the size of the myocardial infarction. The hypothesis of this study is that the administration of Cyclosporin A to these patients, in addition to mechanical reperfusion, is likely to reduce the severity of the multi-organ failure associated with the cardiogenic shock and improve clinical outcome.
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
- •Patients ( male or female), aged over 18, without any legal protection measure
- •Having a health coverage
- •Presenting within 12 hours of the onset of chest pain, with a ST segment elevation or non ST elevation and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI) primary or rescue
- •Occlusion of culprit coronary artery (TIMI flow grade = 0 or 1) at the time of admission in the catheterism laboratory
- •Patient presenting a cardiogenic shock defined by a SBP<90mmhg for a period over 30 minutes and do not answering to a test of vascular charge associated with signs peripheral hypoperfusion (cold extremities, cyanosis, oliguria with urine output <50 ml/h or alteration of higher mental functions).
- •Clear information is delivered to the patient or a legal representative if present and preliminary oral consent obtained, followed by obtaining written consent signed as soon as possible, in accordance with ICH.
- •NB: Patients undergoing either primary PCI or rescue PCI are eligible for the study.
- •Patients with previous AMI, PCI or coronary artery bypass surgery (CABG) are eligible for the study.
排除标准
- •TIMI flow grade >1
- •Patients in cardiac arrest
- •Patients with mechanical complication of myocardial infarction at admission (septal, broken pillar cracking or myocardial rupture, tamponade).
- •Patients with other causes of hemodynamic shock: hemorrhagic, septic or anaphylactic.
- •Patients with known hypersensitivity to cyclosporine, hypersensitivity to egg, peanut or Soya-bean proteins
- •Renal insufficiency (either known creatinine clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency)
- •Patients treated with any compound containing Hypericum perforatum (St. John's Wort) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
- •Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
- •Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation, cancer, lymphoma, known positive serology for HIV, or hepatitis
- •Participation to another clinical trial
研究组 & 干预措施
CsA Group
干预措施: Single bolus of cyclosporine A (CicloMulsion®, Neurovive) (Drug)
Placebo group
干预措施: Single bolus of Placebo of CicloMulsion® (Neurovive). (Drug)
结局指标
主要结局
multiorgan failure evaluated by the SOFA score
时间窗: At 24 hours after admission
The SOFA clinico-biological score takes into account the respiratory status, cardiac, hepatic, renal, neurological and the biological parameters of coagulation of the patient. This score is spread from 0 to 24 points.
次要结局
- multiorgan failure by SOFA score(At 48 hours after admission)
- multiorgan failure by SAPSII scores(At 24 hours and at 48 hours)
- Cardiac output (CO)(At 24 hours after inclusion)
- Reduction of infarct size(during the first 72 hours after admission)
- Reduction of cardiovascular morbidity and mortality(at 1 month)
- Reduction of Left ventricular remodeling(at 1 month)