Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on Myocardial Infarction Size.

Detailed Description
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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.

Official Title
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The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Nitric Oxide
* Drug: MI size at 48-72 hours


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitric Oxide<br>nitric oxide for inhalation | Drug: Nitric Oxide<br>* MI size at 48-72 hours<br>* Other names: vasoKINOX 450;|
| Placebo Comparator: Placebo<br>inhalation gas | Drug: MI size at 48-72 hours<br>* Placebo gas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction size as a fraction of left ventricular size | 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. | 48-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MI size, extent and transmurality of microvascular obstruction | MI size, extent and transmurality of microvascular obstruction measured by MRI | 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 | 
| 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 | 
| 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 | 
| Troponin T levels and CPK-MB area under the curve at 48 hours. |  | 48 hours | 
| 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. | 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 at end-diastole and end-systole. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST Elevation MI, STEMI