Does Cyclosporine ImpRove Clinical oUtcome in ST elevation myocardial infarction patients (CIRCUS study) - CIRCUS

Hospices Civils de Lyon0 个研究点目标入组 970 人开始时间: 2012年7月26日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•1.All (male and female) patients, aged over 18, without any legal protection measure
•2.Having a health coverage
•3.Presenting within 12 hours of the onset of chest pain,
•4.Who have ST segment elevation > 0.2 mV in two contiguous leads,
•5.For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI).
•And (further inclusion criteria to be confirmed by the admission coronary-angiography)
•6.The culprit coronary artery has to be the LAD
•7.The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
•8.Preliminary oral informed consent followed by signed informed consent as soon as possible.
•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.
•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 972
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 972

•1.Patients with loss of consciousness or confused
•2.Patients with cardiogenic shock
•3.Patients with the left circumflex or the right coronary artery (RCA) as the culprit artery, or with evidence of coronary collaterals to the risk region
•4.Patients with an opened (TIMI > 1) LAD coronary artery at admission on initial (admission) coronary angiography
•5.Patients with
•-known hypersensitivity to cyclosporine
•-known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency)
•-known liver insufficiency
•-uncontrolled (treated or untreated) hypertension (> 180/110 mmHg)
•6.Patients treated with
•- any compound containing Hypericum perforatum (St.-John?s-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
•- an active treatment that might modify blood concentration of Cyclosporine (diltiazem, vérapamil?)
•7. Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
•8.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

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