Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
29 participants
INTERVENTIONAL
2006-06-30
2008-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Inhaled Nitric Oxide
Inhaled Nitric oxide administered at 80 parts per million (ppm)
Nitric Oxide
Nitric oxide for inhalation
Placebo
Inhaled nitrogen gas (Placebo) administered at 80 ppm
Placebo
Nitrogen gas (placebo) for inhalation
Interventions
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Nitric Oxide
Nitric oxide for inhalation
Placebo
Nitrogen gas (placebo) for inhalation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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James Baldassarre, MD
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Providence Hospital
Mobile, Alabama, United States
Baptist Cardiac & Vascula Institute
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Jack D. Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
LeBauer Cardiology
Greensboro, North Carolina, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, United States
Central Utah Imaging
Provo, Utah, United States
Virga Jesse Hospital
Hasselt, , Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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INOT 44
Identifier Type: -
Identifier Source: org_study_id
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