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

December 3, 2007
June 27, 2011
June 2006
June 2008   (final data collection date for primary outcome measure)
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).
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 [ Time Frame: 48-72 hours ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00568061 on ClinicalTrials.gov Archive Site
  • 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 ]
MI size at 48-72 hours, size normalized to area at risk at 48-72 hours, myocardial perfusion at coronary angiography at the completion of PCI, Infarct transmurality, Myocardial perfusion at 48-72 hours and 4 months, Global & regional left LV function [ Time Frame: 48-72 hours and 4 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Nitric Oxide in Myocardial Infarction Size
The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Acute Myocardial Infarction
  • ST Elevation MI
  • STEMI
Drug: nitric oxide for inhalation
MI size at 48-72 hours
Other Name: INOmax®
Active Comparator: NO
Intervention: Drug: nitric oxide for inhalation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Belgium
 
NCT00568061
INOT 44
Yes
Rob Small, INO Therapeutics
INO Therapeutics
Not Provided
Study Director: James Baldassarre, MD INO Therapeutics
INO Therapeutics
June 2011

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