The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size. - NOMI

INO Therapeutics0 个研究点目标入组 200 人开始时间: 2008年7月17日最近更新: 2012年6月26日

适应症

试验速览

暂无简介。

•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-V6).
•2.No clinical 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 flow (residual stenosis less than 30% if stented and less than 50% if opened by balloon angioplasty).
•4.Greater than 18 years of age.
•5.Signed IRB approved informed consent.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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.Heart block that is expected to require a temporary pacemaker for greater than 72 hours.
•6.Prior use of thrombolytic therapy for the current event.
•7.Unable to tolerate magnetic resonance imaging (including disallowed metallic implants or BMI >35) or unable to tolerate gadolinium contrast media, including patients with a calculated creatinine clearance less than 60ml/min/ 1.73m2 BSA.
•8.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.
•9.Neutropenia (WBC < 2000 (mm) 3), Anemia (HCT < 30 %), Thrombocytopenia (Thrombocytes < 50,000 (mm) 3). It is not necessary to confirm blood counts prior to start of study drug in the absence of clinical suspicion.
•10.Known or suspected aortic dissection.
•11.Prior history of pulmonary disease requiring chronic oxygen therapy.
•12.Pregnancy, lactating and women of childbearing potential.
•13.Medical problem likely to preclude completion of the study.
•14.Use of investigational drugs or device within the 30 days prior to enrollment to the study.

发起方

INO Therapeutics