IntraCoronary Abciximab with the ClearWay Catheter To Improve Outcomes with Lysis (IC ClearLy) Trial - IC ClearLy

Cardiologia - Azienda Ospedaliero Universitaria di Modena0 个研究点目标入组 130 人开始时间: 2009年10月22日最近更新: 2014年2月17日

试验速览

暂无简介。

•1. Patients (men or women) at least 18 years of age 2. STEMI: Presenting with ischemic chest discomfort >20 minutes and <6 hours of duration suggestive of acute myocardial infarction AND ST elevation > 1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) in two contiguous precordial leads 3. Must have signed the informed consent form prior to performance of study-related procedures 4. Native dominant and proximal culprit vessel ?2.5 mm in diameter 5. Angiographically identifiable thrombus (presence of a filling defect within the coronary lumen surrounded by contrast medium observed in multiple projections, without calcium within the filling defect, or persistence of contrast medium within the coronary lumen) 6. Pre-PCI Thrombus score (TS) ≥2 (angiographically apparent thrombus that is > ? the vessel diameter) 7. Pre-PCI TIMI flow grade of 0-2
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Previous PCI of the IRA 2. Previous myocardial infarction or coronary artery bypass grafting 3. Cardiogenic shock 4. Three vessel disease 5. Left main disease 6. Severe valvular heart disease 7. Rescue PCI (PCI following fibrinolytic administration) 8. Facilitated PCI (PCI following fibrinolytic or GP IIb/IIIa inhibition) 9. Contraindication to GP IIb/IIIa inhibitors such as excess bleeding risk or thrombocytopenia 10. Current participation in another investigational trial 11. Exclusion criteria for the MRI imaging include implanted pacemakers, defibrillators, or metallic intracranial implants, severe claustrophobia, BMI >35 kg/m?, atrial fibrillation or known not well controlled extrasystoles (bad images), or allergy to gadolinium-DTPA 12. Enrolment of patients with an estimated glomerular filtration rate <30ml/min/1.73m2 should be carefully evaluated considering the gadolinium chelate-associated risk of nephrogenic systemic fibrosis.

发起方

Cardiologia - Azienda Ospedaliero Universitaria di Modena