MINeralocorticoid receptor antagonist pretreatment to MINIMISE reperfusion injury after ST-Elevation Myocardial Infarction(STEMI). - MINIMISE STEMI trial version 1

niversity College London (UCL)0 个研究点目标入组 150 人开始时间: 2013年6月6日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•Patients >18 years •Patients presenting with acute STEMI (as assessed by 12 lead ECG;ST segment elevation =2 mm (0.2 mV)in 2 or more contiguous precordial leads or =1mm (0.1mm) in 2 or more adjacent limb leads). •Presentation within 12 hours after symptom onset •Angiographically proven proximal occlusion (TIMI 0) of a major coronary vessel (LAD, LCX, RCA).
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Patients with known LVEF =40% prior to randomisation •Cardiogenic shock (catecholamine support OR systolic blood pressure < 90 mmHg) •Killip class > 2 •Prior myocardial infarction •Potassium > 5.0 mmol/l or known renal failure (> CKD III) or porphyria •known impaired liver function or liver failure •Current treatment with mineralocorticoid receptor antagonists •Pregnant or lactating females •Allergies to IMP or its excipients •Known contraindication to cardiac magnetic resonance imaging (MRI) such as significant claustrophobia, severe allergy to gadolinium chelate contrast, severe renal insufficiency (defined as an estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2, known from previous examinations), presence of MRI contraindicated implanted devices (eg, pacemaker, implanted cardiac defibrillator, cardiac resynchronization therapy device, cochlear implant), imbedded metal objects (eg, shrapnel), or any other contraindication for cardiac MRI Once the current serum creatinine is known, patients with severely compromised renal function (eGFR < 30 ml/min/1.73 m2) will also be excluded. Patients with known porphyria. Patients with significant liver dysfunction (INR>2). Patients with known contraindications to treatment with spironolactone.

发起方

niversity College London (UCL)