Nitric Oxide in Myocardial Infarction Size

Study Overview
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Brief Summary
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The purpose of this study is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention.

Detailed Description
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The purpose 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 (PCI). The primary endpoint for this study will be myocardial infarction size as a fraction of left ventricular size at 48-72 hours as measured by contrast-enhanced cardiac MRI.

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, ST Elevation MI, STEMI

Intervention / Treatment
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* Drug: Nitric Oxide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute myocardial infarction and electrocardiographic evidence of ST elevation No clinical evidence of congestive heart failure All patients must undergo successful percutaneous coronary intervention for thrombolysis in myocardial infarction (TIMI) 0 or 1 coronary flow with resulting TIMI 2 or 3 flow Greater than 18 years of age Signed Institutional Review Board (IRB) approved informed consent Exclusion Criteria: Prior myocardial infarction Requirement for urgent cardiac surgery Previous coronary artery bypass graft (CABG) or primary coronary intervention (PCI) Left bundle branch block Heart block that is expected to require a temporary pacemaker for greater than 72 hours Prior use of thrombolytic therapy for the current event Unable to tolerate magnetic resonance imaging or unable to tolerate gadolinium contrast media, including patients with a calculated creatinine clearance less than 60 ml/min/1.73m² Body Surface Area (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 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. Known or suspected aortic dissection. Prior history of pulmonary disease requiring chronic oxygen therapy. Pregnancy, lactating, and women of childbearing potential. Medical problem likely to preclude completion of the study. Use of investigational drugs or device within the 30 days prior to enrollment

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 |
| --- | --- |
| Experimental: Inhaled Nitric Oxide<br>Inhaled Nitric oxide administered at 80 parts per million (ppm) | Drug: Nitric Oxide<br>* Nitric oxide for inhalation<br>* Other names: INOmax®;|
| Placebo Comparator: Placebo<br>Inhaled nitrogen gas (Placebo) administered at 80 ppm | Drug: Placebo<br>* Nitrogen gas (placebo) for inhalation<br>* Other names: Nitrogen gas;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size | The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI). | 48-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Infarction (MI) Size at 48-72 Hours |  | 48-72 hours | 
| MI Size Normalized to Area at Risk |  | 48-72 hours | 
| Myocardial Perfusion at Coronary Angiography |  | at completion of primary coronary intervention (PCI) | 
| Infarct Transmurality |  | 48-72 hours and 4 months | 
| Global & Regional Left Ventricular (LV) Function and LV Mass |  | 48-72 hours and 4 months | 
| Change in Global LV Function and Mass |  | between 48-72 hours and 4 months | 
| MI Size as a Fraction of LV Size |  | 4 months | 
| Resolution of ST Segment Elevation Compared With That Observed at Enrollment |  | 4 hours | 
| Troponin T Levels and CPK-MB Area Under the Curve |  | 48 hours | 
| Change in Adverse Remodeling Parameters Compared With 48-72 Hrs: Changes in LV End-diastolic Vol, End-systolic Vol, End-diastolic Myocardial Wall Thickness in Infarct, Peri-infarct and Remote Areas, and in Sphericity Index at End-diastole and End-systole |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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INOT44, NOMI