Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size (NOMI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01398384
First received: July 18, 2011
Last updated: May 20, 2014
Last verified: May 2014

July 18, 2011
May 20, 2014
October 2010
May 2014   (final data collection date for primary outcome measure)
Myocardial infarction size as a fraction of left ventricular size [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01398384 on ClinicalTrials.gov Archive Site
  • MI size, extent and transmurality of microvascular obstruction [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    MI size, extent and transmurality of microvascular obstruction measured by MRI
  • MI size normalized to area at risk [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Transmurality of infarct (as average percent wall thickness in all segments showing delayed enhancement). [ Time Frame: at 48 - 72 hours and 4 months ] [ Designated as safety issue: No ]
  • Myocardial perfusion(MRI). [ Time Frame: at 48-72 hours and 4 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Troponin T levels and CPK-MB area under the curve at 48 hours. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size
The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Drug: Nitric Oxide
    MI size at 48-72 hours
    Other Name: vasoKINOX 450
  • Drug: MI size at 48-72 hours
    Placebo gas
  • Active Comparator: Nitric Oxide
    nitric oxide for inhalation
    Intervention: Drug: Nitric Oxide
  • Placebo Comparator: Placebo
    inhalation gas
    Intervention: Drug: MI size at 48-72 hours
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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).
  2. No evidence of congestive heart failure (no S3 or evidence of pulmonary edema) and normal oxygen saturation on ≤ 2L oxygen by NC.
  3. 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).
  4. Age > 18 years.
  5. Signed EC approved informed consent.

Exclusion Criteria:

  1. Prior myocardial infarction (as determined by patient history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic or valvular heart disease.
  2. Requirement for urgent cardiac surgery.
  3. Previous CABG or PCI.
  4. Left bundle branch block.
  5. 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.
  6. 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.
  7. Known or suspected aortic dissection.
  8. Prior history of pulmonary disease requiring chronic oxygen therapy.
  9. Pregnancy, lactating and woman of childbearing potential.
  10. Use of investigational drugs or device within the 30 days prior to enrollment to the study. Investigational uses of approved therapies will be allowed.
  11. Medical problem likely to preclude completion of the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Hungary,   Poland
 
NCT01398384
LCC2010.01
Yes
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Stefan Janssens, Prof Dr UZ Leuven
Principal Investigator: Frans Van de Werf, Prof Dr UZ Leuven
Universitaire Ziekenhuizen Leuven
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP