Nitric Oxide in Myocardial Infarction Size (NOMI)

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.

Study Overview

• Status: Terminated
• Conditions: Acute Myocardial Infarction; STEMI; ST Elevation MI
• Intervention / Treatment: Drug: Nitric Oxide; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 thrombolysis in myocardial infarction (TIMI) 0 or 1 coronary flow with resulting TIMI 2 or 3 flow
• Greater than 18 years of age
• Signed Institutional Review Board (IRB) approved informed consent

Exclusion Criteria:

• Prior myocardial infarction
• Requirement for urgent cardiac surgery
• Previous coronary artery bypass graft (CABG) or primary coronary intervention (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 60 ml/min/1.73m² Body Surface Area (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inhaled Nitric Oxide; Inhaled Nitric oxide administered at 80 parts per million (ppm)	Drug: Nitric Oxide; Nitric oxide for inhalation; Other Names: INOmax®
Placebo Comparator: Placebo; Inhaled nitrogen gas (Placebo) administered at 80 ppm	Drug: Placebo; Nitrogen gas (placebo) for inhalation; Other Names: Nitrogen gas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size	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).	48-72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Myocardial Infarction (MI) Size at 48-72 Hours	48-72 hours
MI Size Normalized to Area at Risk	48-72 hours
Myocardial Perfusion at Coronary Angiography	at completion of primary coronary intervention (PCI)
Infarct Transmurality	48-72 hours and 4 months
Global & Regional Left Ventricular (LV) Function and LV Mass	48-72 hours and 4 months
Change in Global LV Function and Mass	between 48-72 hours and 4 months
MI Size as a Fraction of LV Size	4 months
Resolution of ST Segment Elevation Compared With That Observed at Enrollment	4 hours
Troponin T Levels and CPK-MB Area Under the Curve	48 hours
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	4 months

Collaborators and Investigators

• Sponsor: Mallinckrodt
• Investigators: Study Director: James Baldassarre, MD, Mallinckrodt

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: December 3, 2007
• First Submitted That Met QC Criteria: December 3, 2007
• First Posted (Estimate): December 5, 2007

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: NOMI; INOT44
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: INOT 44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO