EUCTR2007-002931-95-HU进行中（未招募）不适用
The effects of Nitric Oxide for Inhalation on MYocardial Infarction Size - NOMI
Z Leuven0 个研究点目标入组 200 人开始时间: 2011年9月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 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 ? 0.6 mV in leads I, II, III, AVL, AVF, V1-
- •2. No evidence of congestive heart failure (no S3 or evidence of
- •pulmonary edema) and normal oxygen saturation on = 2L oxygen by NC.
- •3. 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).
- •4. Age > 18 years.
- •5. Signed EC approved informed consent.
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Prior myocardial infarction (as determined by patient history and/or
- •ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic
- •or valvular heart disease.
- •2. Requirement for urgent cardiac surgery.
- •3. Previous CABG or PCI.
- •4. Left bundle branch block.
- •5. 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.
- •6. 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.
- •7. Known or suspected aortic dissection.
- •8. Prior history of pulmonary disease requiring chronic oxygen therapy.
- •9. Pregnancy, lactating and woman of childbearing potential.
- •10. Use of investigational drugs or device within the 30 days prior to
- •enrollment to the study. Investigational uses of approved therapies will
- •be allowed.
- •11. Medical problem likely to preclude completion of the study.
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