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Nitric Oxide in Myocardial Infarction Size (NOMI)

This study has been terminated.
(Slow Enrollment)
Sponsor:
Information provided by:
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT00568061
First received: December 3, 2007
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
ST Elevation MI
STEMI
 Drug: nitric oxide for inhalation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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 INO Therapeutics:

Primary Outcome Measures:
  • Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • MI Size at 48-72 Hours [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • MI Size Normalized to Area at Risk [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Myocardial Perfusion at Coronary Angiography [ Time Frame: at completion of PCI ] [ Designated as safety issue: No ]
  • Infarct Transmurality [ Time Frame: 48-72 hours and 4 months ] [ Designated as safety issue: No ]
  • Global & Regional LV Function and LV Mass [ Time Frame: 48-72 hours and 4 months ] [ Designated as safety issue: No ]
  • Change in Global LV Function and Mass [ Time Frame: between 48-72 hours and 4 months ] [ Designated as safety issue: No ]
  • MI Size as a Fraction of LV Size [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Resolution of ST Segment Elevation Compared With That Observed at Enrollment [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Troponin T Levels and CPK-MB Area Under the Curve [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: June 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NO Drug: nitric oxide for inhalation
MI size at 48-72 hours
Other Name: INOmax®

Detailed Description:

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.

  Eligibility

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

Inclusion Criteria:

  • Acute myocardial infarction and electrocardiographic evidence of ST elevation
  • No clinical evidence of congestive heart failure
  • All patients must undergo successful percutaneous coronary intervention for TIMI 0 or 1 coronary flow with resulting TIMI 2 or 3 flow
  • Greater than 18 years of age
  • Signed IRB approved informed consent

Exclusion Criteria:

  • Prior myocardial infarction
  • Requirement for urgent cardiac surgery
  • Previous CABG or PCI
  • Left bundle branch block
  • Heart block that is expected to require a temporary pacemaker for greater than 72 hours
  • Prior use of thrombolytic therapy for the current event
  • Unable to tolerate magnetic resonance imaging or unable to tolerate gadolinium contrast media, including patients with a calculated creatinine clearance less than 60ml/min/1.73m² 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
  • Neutropenia (WBC <2000 (mm)³), Anemia (HCT <30%, Thrombocytopenia (Thrombocytes <50,000 (mm)³). It is not necessary to confirm blood counts prior to start of study drug in the absence of clinical suspicion.
  • Known or suspected aortic dissection.
  • Prior history of pulmonary disease requiring chronic oxygen therapy.
  • Pregnancy, lactating, and women of childbearing potential.
  • Medical problem likely to preclude completion of the study.
  • Use of investigational drugs or device within the 30 days prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568061

Locations
United States, Alabama
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Florida
Baptist Cardiac & Vascula Institute
Miami, Florida, United States, 33176
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Jack D. Weiler Hospital
Bronx, New York, United States, 10467
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, North Carolina
LeBauer Cardiology
Greensboro, North Carolina, United States, 27401
United States, Pennsylvania
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, United States, 15213
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Utah
Central Utah Imaging
Provo, Utah, United States, 84604
Belgium
Virga Jesse Hospital
Hasselt, Belgium, 3500
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, TGG 2B7
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
INO Therapeutics
Investigators
Study Director: James Baldassarre, MD INO Therapeutics
  More Information

No publications provided

Responsible Party: Rob Small, INO Therapeutics
ClinicalTrials.gov Identifier: NCT00568061     History of Changes
Other Study ID Numbers: INOT 44
Study First Received: December 3, 2007
Results First Received: August 3, 2010
Last Updated: June 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by INO Therapeutics:
INOT44
NOMI

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 23, 2013