The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on Myocardial Infarction Size.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
MI size at 48-72 hours
Placebo gas
Jessa Hospital
Hasselt, Belgium
UZ Leuven
Leuven, Belgium
Semmelweis University Heart Center
Budapest, Hungary
John Paul II Hospital
Krakow, Poland
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.
Time frame: 48-72 hours
MI size, extent and transmurality of microvascular obstruction
MI size, extent and transmurality of microvascular obstruction measured by MRI
Time frame: 48-72 hours
MI size normalized to area at risk
Time frame: 48-72 hours
Myocardial perfusion at coronary angiography at the completion of PCI (corrected TIMI frame count and myocardial blush grade).
Time frame: at completion of PCI, as expected 1 day
Transmurality of infarct (as average percent wall thickness in all segments showing delayed enhancement).
Time frame: at 48 - 72 hours and 4 months
Myocardial perfusion(MRI).
Time frame: 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.
Time frame: 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.
Time frame: at 4 hours
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Troponin T levels and CPK-MB area under the curve at 48 hours.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
Assess the safety of inhaled NO for this use as determined by reported adverse events (including bleeding and laboratory changes).
Time frame: during treatment gas period, an average of 6 hours