Nitric Oxide in Myocardial Infarction Size (NOMI)
This study has been terminated.
(Slow Enrollment)
Sponsor:
Mallinckrodt
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00568061
First received: December 3, 2007
Last updated: May 12, 2016
Last verified: May 2016
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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 Intervention Model: Single Group Assignment Masking: Double Blind (Participant, 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 ]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 ]
- MI Size Normalized to Area at Risk [ Time Frame: 48-72 hours ]
- Myocardial Perfusion at Coronary Angiography [ Time Frame: at completion of PCI ]
- Infarct Transmurality [ Time Frame: 48-72 hours and 4 months ]
- Global & Regional LV Function and LV Mass [ Time Frame: 48-72 hours and 4 months ]
- Change in Global LV Function and Mass [ Time Frame: between 48-72 hours and 4 months ]
- MI Size as a Fraction of LV Size [ Time Frame: 4 months ]
- Resolution of ST Segment Elevation Compared With That Observed at Enrollment [ Time Frame: 4 hours ]
- Troponin T Levels and CPK-MB Area Under the Curve [ Time Frame: 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 [ Time Frame: 4 months ]
| 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) |
| 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
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
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 |
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 May 25, 2017