Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size
- Conditions
- Acute Myocardial Infarction
- Interventions
- Drug: MI size at 48-72 hours
- Registration Number
- NCT01398384
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on Myocardial Infarction Size.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo MI size at 48-72 hours inhalation gas Nitric Oxide Nitric Oxide nitric oxide for inhalation
- Primary Outcome Measures
Name Time Method Myocardial infarction size as a fraction of left ventricular size 48-72 hours 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.
- Secondary Outcome Measures
Name Time Method MI size, extent and transmurality of microvascular obstruction 48-72 hours MI size, extent and transmurality of microvascular obstruction measured by MRI
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. 4 months 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.
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
Trial Locations
- Locations (4)
Jessa Hospital
🇧🇪Hasselt, Belgium
John Paul II Hospital
🇵🇱Krakow, Poland
Semmelweis University Heart Center
🇭🇺Budapest, Hungary
UZ Leuven
🇧🇪Leuven, Belgium