Nitric Oxide in Myocardial Infarction Size - Full Text View

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

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by Mallinckrodt:

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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


Responsible Party:	Mallinckrodt
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:	May 12, 2016
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 29, 2016

Nitric Oxide in Myocardial Infarction Size (NOMI)