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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
Nitric oxide for inhalation
Nitrogen gas (placebo) for inhalation
Providence Hospital
Mobile, Alabama, United States
Baptist Cardiac & Vascula Institute
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
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).
Time frame: 48-72 hours
Myocardial Infarction (MI) Size at 48-72 Hours
Time frame: 48-72 hours
MI Size Normalized to Area at Risk
Time frame: 48-72 hours
Myocardial Perfusion at Coronary Angiography
Time frame: at completion of primary coronary intervention (PCI)
Infarct Transmurality
Time frame: 48-72 hours and 4 months
Global & Regional Left Ventricular (LV) Function and LV Mass
Time frame: 48-72 hours and 4 months
Change in Global LV Function and Mass
Time frame: between 48-72 hours and 4 months
MI Size as a Fraction of LV Size
Time frame: 4 months
Resolution of ST Segment Elevation Compared With That Observed at Enrollment
Time frame: 4 hours
Troponin T Levels and CPK-MB Area Under the Curve
Time frame: 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
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University of Kansas Hospital
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Jack D. Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
LeBauer Cardiology
Greensboro, North Carolina, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, United States
...and 4 more locations
Time frame: 4 months