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

This study is currently recruiting participants.
Verified January 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01398384
First received: July 18, 2011
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on Myocardial Infarction Size.


Condition Intervention Phase
Acute Myocardial Infarction
 Drug: Nitric Oxide
Drug: MI size at 48-72 hours
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 230
Study Start Date: October 2010
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nitric Oxide
nitric oxide for inhalation
 Drug: Nitric Oxide
MI size at 48-72 hours
Other Name: vasoKINOX 450
Placebo Comparator: Placebo
inhalation gas
 Drug: MI size at 48-72 hours
Placebo gas

Detailed Description:

The primary objective of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infartion (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398384

Contacts
Contact: Stefan janssens, Prof +3216344235 stefan.janssens@uzleuven.be

Locations
Belgium
Jessa Hospital Recruiting
Hasselt, Belgium
Contact: Pascal Vranckx, Dr         pascal.vranckx@jessazh.be    
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Stefan Janssens, Prof Dr     +32 16344235     stefan.janssens@uzleuven.be    
Hungary
Semmelweis University Heart Center Recruiting
Budapest, Hungary, 1122
Contact: Bela Merkely, Prof Dr         merkelybela@kardio.sote.hu    
Poland
John Paul II Hospital Recruiting
Krakow, Poland, 31-202
Contact: Krzysztof Zmudka, Dr         k.smudka@szpitaljp2.krakow.pl    
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Stefan Janssens, Prof Dr UZ Leuven
Principal Investigator: Frans Van de Werf, Prof Dr UZ Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01398384     History of Changes
Other Study ID Numbers: LCC2010.01
Study First Received: July 18, 2011
Last Updated: January 23, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
ST Elevation MI
STEMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013