Ensayo clínico, Fase III, Aleatorizado, Prospectivo, unicéntrico, Doble Ciego y Controlado Con Placebo, Para Estimar la Eficacia y Seguridad Del Levosimendan Intravenoso, en Las Primeras 24 Horas Tras la Angioplastia Primaria, en Pacientes Con síndrome Coronario Agudo Con elevación Del Segmento ST
试验速览
- 阶段
- 3 期
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Size of acute myocardial infarction
研究概览
简要总结
The disease under study is acute coronary syndrome with ST segment elevation, defined as patients presenting chest pain of anginal characteristics of more than 20 minutes of duration, with changes in the electrocardiogram consisting of ST segment elevation of 1 mm in two contiguous limb leads or 2 mm in two contiguous leads precordial. In a review carried out on patients treated in the investigator center with SCACEST, invetsigators found that, in a cohort of 250 patients, 85% of them presented alterations Segments of left ventricular contractility at 4 months after the acute episode. To verify that the Levosimendan administration reduces that percentage, at least 65%, investigators require to include in the study 83 patients in the experimental group and 83 in the control group, for a power of 80% and a confidence level of 95%. Assuming 10% of lost patients, it is required to include in the study 92 patients in the experimental group and 92 patients in the group control .
详细描述
The patients will be included randomly, until the calculated sample size is completed. A recruitment period of 12 months is estimated from the beginning of the study. From the date of inclusion of the first patient, the final duration of the study will be 1.5 years.
The study will end when performing the last cardio-resonance and echocardiography that should be performed 6 months after the inclusion of the last patient in the study.
Upon arrival of the patient at the Coronary Unit, he will receive, in a randomized and double-blind manner, without a loading dose, the 24-hour infusion of Levosimendan, or placebo.
The continuous infusion of levosimendan 0.1 micrograms / kg / min will be administered during 24h. If the initial dose is tolerated and a greater hemodynamic effect is needed, the infusion rate can be increased to 0.2 micrograms / kg / min. The dose of Levosimendan infusion can be reduced to 0.05 μg / kg / min in case of clinical intolerance or systolic hypotension <90 mmHg.
Continuous perfusion of the placebo 0.1 micrograms / kg / min will be administered for 24h. If the initial dose is tolerated and a greater hemodynamic effect is needed, the infusion rate can be increased to 0.2 micrograms / kg / min. The dose of infusion of the placebo can be reduced to 0.05 μg / kg / min in case of clinical intolerance or systolic hypotension <90 mmHg.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Patients agreed to participate in the study and have signed the informed consent.
- •The same patient may not be included more than once.
排除标准
- •Killip IV class in a situation of cardiogenic shock or with TAM values below 65 mmHg of pressure.
- •Patients that have suffered a previous heart attack.
- •Patients who are being administered amines.
- •Patients that do not have segmental disorders of contractility in left ventriculography.
- •Mental circumstance that makes you unable to participate in the study.
- •Patients that refuse to participate in the study and that they do not sign the informed consent.
- •Severe renal impairment (creatinine clearance <30ml / min)
- •Severe hepatic insufficiency - (prothrombin activity rate <40%).
- •History of Torsades de Pointes.
- •Acute respiratory distress
- •Allergy to levosimendan or some of its components
- •Anemia (hemoglobin <8g / dl)
- •Pregnancy
研究组 & 干预措施
placebo
solution for intravenous infusion, with similar organoleptic characteristics than active treatment.
干预措施: Placebos (Drug)
levosimendan
Concentrate for solution for perfusion. Pack with a 5 ml vial
干预措施: Levosimendan (Drug)
结局指标
主要结局
Size of acute myocardial infarction
时间窗: 30 days after acute episode
percentage myocardium infarct/ left ventricle ventricle
次要结局
- measurement of Biochemical parameters function(first 24 hours)
- electrocardiogram parameters(1 hour after primary angioplasty)
- MAJOR CARDIAC EVENTS(6 months after angioplasty)