The Impact of Oxytocin Administration on Short and Long Term Prognosis in Patients Undergoing ST Elevation Myocardial Infarction
试验速览
- 阶段
- 2 期
- 入组人数
- 52
- 主要终点
- final infarction size
研究概览
简要总结
60 patients admitted to this ICCU at the Sheba medical Center will be randomly divided in to 2 groups. one group will receive the conventional treatment while the second group will receive the conventional treatment plus oxytocin infusion for 48 hours. all participants will undergo echo and cMRI during hospitalization.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 18 years
- •current diagnosis of ST elevation myocardial infarction
- •no previous episodes of acute coronary syndrome
- •agreed to enter research
排除标准
- •age < 18 years
- •congestive heart failure (acute or chronic)
- •cardiomyopathy
- •life threatening arrhythmia at presentation
- •previous LV dysfunction
- •hypotension (systolic < 100mmHg, diastolic<50mmHg, 15% less than patients normal values)
- •tachycardia - pulse > 100bpm
- •bradycardia - pulse < 55 ppm
- •killip 3 or 4 at presentation
- •current use of nitrates
- •pregnancy
- •females - history of pathological GU bleeding
- •inability to give consent
研究组 & 干预措施
conventional treatment and oxytocin
26 patients admitted to the ICCU under a diagnosis of STEMI will receive treatment with oxytocin as an add on to the conventional treatment (e.g. primary PCI, aspirin, ADP receptor inhibitors, high dose statin, beta blockers & ACE inhibitors). At admission, a continuance infusion with oxytocin will be initiated for a time period of 6 hours. 10 units of oxytocin will be diluted in 1 liter of 0.9% normal saline. the infusion will start at a rate of 2.5 milliunits/min. dosage will be increased at a rate of 5 milliuinits/min every 30 min if there are no side effect, up to a maximum dosage of 30 milliunits/min.
干预措施: Oxytocin (Drug)
conventional treatment only
26 patients admitted to the ICCU under a diagnosis of STEMI will receive the conventional treatment (e.g. primary PCI, aspirin, ADP receptor inhibitors, high dose statin, beta blockers & ACE inhibitors). On admission, an infusion of 0.9 normal saline will be stared as placebo.
干预措施: Placebos (Drug)
结局指标
主要结局
final infarction size
时间窗: 1 week
all patients will undergo an cMRI after 7 days
次要结局
- Ejection fraction(48 hours)