Nitric Oxide in Myocardial Infarction Size (NOMI)

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Acute Myocardial Infarction; ST Elevation MI; STEMI	Drug: nitric oxide for inhalation	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	29 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size
Study Start Date :	June 2006
Actual Primary Completion Date :	June 2008
Actual Study Completion Date :	June 2008

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: NO	Drug: nitric oxide for inhalation; MI size at 48-72 hours; Other Name: INOmax®

Outcome Measures

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Primary Outcome Measures :

1. Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size [ Time Frame: 48-72 hours ]
   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 :

1. MI Size at 48-72 Hours [ Time Frame: 48-72 hours ]
2. MI Size Normalized to Area at Risk [ Time Frame: 48-72 hours ]
3. Myocardial Perfusion at Coronary Angiography [ Time Frame: at completion of PCI ]
4. Infarct Transmurality [ Time Frame: 48-72 hours and 4 months ]
5. Global & Regional LV Function and LV Mass [ Time Frame: 48-72 hours and 4 months ]
6. Change in Global LV Function and Mass [ Time Frame: between 48-72 hours and 4 months ]
7. MI Size as a Fraction of LV Size [ Time Frame: 4 months ]
8. Resolution of ST Segment Elevation Compared With That Observed at Enrollment [ Time Frame: 4 hours ]
9. Troponin T Levels and CPK-MB Area Under the Curve [ Time Frame: 48 hours ]
10. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, United States, 15213
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

Mallinckrodt

Investigators

Study Director:	James Baldassarre, MD	Mallinckrodt

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mallinckrodt
ClinicalTrials.gov Identifier:	NCT00568061 History of Changes
Other Study ID Numbers:	INOT 44
First Posted:	December 5, 2007
Results First Posted:	August 27, 2010
Last Update Posted:	June 16, 2016
Last Verified:	May 2016

Keywords provided by Mallinckrodt:

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; Anti-Asthmatic Agents; Respiratory System Agents; Free Radical Scavengers; Antioxidants; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Endothelium-Dependent Relaxing Factors; Vasodilator Agents; Gasotransmitters; Protective Agents