Myocardial Infarction MedDRA version: 14.1 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: VASOkinox 450 ppm (nitric oxide) for inhalation
Product Name: VASOkinox 450 ppm (nitric oxide) for inhalation
Product Code: n/a
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: nit
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient must meet the following criteria: 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 evidence of congestive heart failure (no S3 or evidence of pulmonary edema) and normal oxygen saturation on = 2L oxygen by NC. 3. Age > 18 years. 4. Signed EC 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 92 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 138
Exclusion criteria
Exclusion criteria: The patient will be excluded from enrollment if any of the following are true: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 (LV) size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention.;Secondary Objective: The secondary objectives of the trial are to assess impact of NO inhalation on: 1. MI size at 48–72 h (MRI). 2. MI size normalized to area at risk at 48–72 h (MRI). 3. Myocardial perfusion after PCI. 4. MI transmurality at 48–72 h and 4 months. 5. Myocardial perfusion at 48-72 h and 4 months (MRI). 6. Global & regional left ventricular (LV) function and LV mass at 48–72 h and 4 months after MI. MI size as a fraction of LV size at 4 months after MI. 7. Resolution of ST segment elevation at 4 h compared to enrollment. 8. Troponin T levels & CPK-MB area under the curve at 48 h. 9. Change between 48-72 h and 4 months in LV end-diastolic volume; end-systolic volume; end-diastolic myocardial wall thickness in infarct, peri-infarct & remote areas; & sphericity index at end-diastole & end-systole. 10. Death; nonfatal recurrent MI; recurrent ischemia necessitating re-hospitalization, PCI, or surgical revascularization; & stroke at 4 months. 11. Safety-determined by reported AEs.;Primary end point(s): The primary efficacy variable for this study will be myocardial infarction size as a fraction of left ventricular size as measured by contrast-enhanced cardiac MRI.;Timepoint(s) of evaluation of this end point: at 48-72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 48-72 hours and at 4 months;Secondary end point(s): 1. MI size, extent and transmurality of microvascular obstruction at 48 – 72 hours (MRI). 2. MI size normalized to area at risk at 48 – 72 hours (MRI). 3. Myocardial perfusion at coronary angiography at the completion of PCI (corrected TIMI frame count and myocardial blush grade). 4. Infarct transmurality (as average percent wall thickness in all segments showing delayed enhancement) at 48 – 72 hours and 4 months. 5. Myocardial perfusion at 48 – 72 hours and 4 months (MRI). 6. 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 at4 months after MI. 7. 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. 8. Troponin T levels and CPK-MB area under the curve at 48 hours. 9. Change in adverse remodeling parameters at 4 months (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 at end-diastole and endsystole. 10. Incidence of death; nonfatal recurrent myocardial infarction; 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. 11. Assess the safety of inhaled NO for this use as determined by reported adverse events (including bleeding and laboratory changes). | — |
Countries
Belgium, Germany, Hungary
Contacts
Public ContactLeuven Coordinating Centre
UZ Leuven
Outcome results
None listed