Clinical trial, Phase III, randomized, prospective, unicentric, double-blind and placebo-controlled, to estimate the efficacy and safety of intravenous Levosimendan, in the first 24 hours after primary angioplasty, in patients with acute coronary syndrome with ST-segment elevation.

Hospital Universitario de Canarias- Dr. Francisco Bosa Ojeda0 个研究点目标入组 184 人开始时间: 2018年1月17日最近更新: 2023年10月23日

适应症

试验速览

暂无简介。

•Patients of both sexes who come to CHUC.
•Age between 18 and 85 years old.
•Symptoms of STEMI over 30 minutes and less than 12 hours of evolution.
•ST segment elevation of >= 1 mm in two contiguous limb leads or >= 2 mm in two contiguous precordial leads.
•That they agreed to participate in the study and have signed the informed consent.
•The same patient may not be included more than once.
•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 84
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Class Killip IV in cardiogenic shock situation or with Arterial Pressure below 80 mmHg systolic pressure.
•That they had a previous heart attack.
•who don't have contractility disorders on their left ventriculography.
•Mental circumstance that makes you unable to participate in the study.
•Refuse to participate in the study and not sign an informed consent form.
•Severe renal failure (creatinine clearance < 30ml/min)
•Severe liver failure (define).
•History of Torsades de Pointes.
•Acute respiratory distress
•Allergy to levosimendan or some of its components
•Anemia (hemoglobin < 8g/dl)

发起方

Hospital Universitario de Canarias- Dr. Francisco Bosa Ojeda