NCT01398384已完成2 期
The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Myocardial infarction size as a fraction of left ventricular size
研究概览
简要总结
The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on Myocardial Infarction Size.
详细描述
The primary objective of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction (defined as an episode of chest pain or related symptom lasting greater than 2 hours but less than 12 hours and electrocardiographic evidence of ST elevation (measured as 0.08 seconds after the J point; sum greater or equal to 0.6 mV in leads I, II, III, AVL, AVF, V1-V6).
- •No evidence of congestive heart failure (no S3 or evidence of pulmonary edema) and normal oxygen saturation on ≤ 2L oxygen by NC.
- •All patients must undergo successful percutaneous coronary intervention for TIMI 0 or 1 coronary flow with resulting TIMI 2 or 3 (residual stenosis less than 30% if stented and less than 50% if opened by balloon angioplasty).
- •Age > 18 years.
- •Signed EC approved informed consent.
排除标准
- •Prior myocardial infarction (as determined by patient history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic or valvular heart disease.
- •Requirement for urgent cardiac surgery.
- •Previous CABG or PCI.
- •Left bundle branch block.
- •Unable to tolerate magnetic resonance imaging (including disallowed metallic implants or BMI > 35) or unable to tolerate gadolinium contrast media, including patients with calculated creatinine clearance less than 60 ml/min/1.73 m2 BSA.
- •Active or recent hemorrhage requiring an invasive procedure for evaluation or transfusion within 6 weeks prior to presentation or hemorrhagic stroke within the 6 weeks prior to presentation.
- •Known or suspected aortic dissection.
- •Prior history of pulmonary disease requiring chronic oxygen therapy.
- •Pregnancy, lactating and woman of childbearing potential.
- •Use of investigational drugs or device within the 30 days prior to enrollment to the study. Investigational uses of approved therapies will be allowed.
- •Medical problem likely to preclude completion of the study.
研究组 & 干预措施
Nitric Oxide
Active Comparator
nitric oxide for inhalation
干预措施: Nitric Oxide (Drug)
Placebo
Placebo Comparator
inhalation gas
干预措施: MI size at 48-72 hours (Drug)
结局指标
主要结局
Myocardial infarction size as a fraction of left ventricular size
时间窗: 48-72 hours
Myocardial infarction size as a fraction of left ventricular size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention.
次要结局
- Troponin T levels and CPK-MB area under the curve at 48 hours.(48 hours)
- Resolution of ST segment elevation (serial ECGs) as indicated by the decrease in the total ST elevation (in mV) at 4 hours compared with that observed at enrollment.(at 4 hours)
- Global and regional left ventricular function and left ventricular mass at 48 - 72hours and 4 months after MI and the change in global LV function and mass between 48-72 hours and 4 months. MI size as a fraction of LV size at 4 months after MI.(48-72 hours and 4 months)
- MI size, extent and transmurality of microvascular obstruction(48-72 hours)
- MI size normalized to area at risk(48-72 hours)
- Myocardial perfusion at coronary angiography at the completion of PCI (corrected TIMI frame count and myocardial blush grade).(at completion of PCI, as expected 1 day)
- Transmurality of infarct (as average percent wall thickness in all segments showing delayed enhancement).(at 48 - 72 hours and 4 months)
- Myocardial perfusion(MRI).(at 48-72 hours and 4 months)
- Change in adverse remodeling parameters (compared with 48-72 hours):changes in LV end-diastolic volume, end-systolic volume, end-diastolic myocardial wall thickness in infarct, peri-infarct and remote areas and in sphericity index.(4 months)
- Death, nonfatal recurrent MI, recurrent ischemia necessitating re-hospitalization, PCI, or surgical revascularization, and stroke (i.e. combined CV endpoint) at 4 months. Enzyme leak during subsequent scheduled PCI will not be considered new ischemia/MI.(4 months)
- Assess the safety of inhaled NO for this use as determined by reported adverse events (including bleeding and laboratory changes).(during treatment gas period, an average of 6 hours)
研究者
研究点 (4)
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