Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-01-31 @ 7:30 AM
Study NCT ID:
NCT00568061
Status:
TERMINATED
Last Update Posted:
2019-11-21
First Post:
2007-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nitric Oxide in Myocardial Infarction Size
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009569', 'term': 'Nitric Oxide'}, {'id': 'D045462', 'term': 'Endothelium-Dependent Relaxing Factors'}, {'id': 'D009584', 'term': 'Nitrogen'}], 'ancestors': [{'id': 'D026361', 'term': 'Reactive Nitrogen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014665', 'term': 'Vasodilator Agents'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@mnk.com', 'phone': '800-556-3314', 'title': 'Medical Information Call Center', 'organization': 'Mallinckrodt Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The validated summary tables and CSR are not available for this legacy registration that was transferred to us eight years after it was terminated for low enrollment, so posting of results for secondary outcome measures is not possible.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm', 'otherNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retropertioneal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'OG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '11.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48-72 hours', 'description': '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).', 'unitOfMeasure': 'percent of myocardial infarction size', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per intent to treat population'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction (MI) Size at 48-72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitric Oxide', 'description': 'nitric oxide for inhalation'}], 'timeFrame': '48-72 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate data for this historical trial - the validated summary tables and Clinical Study Report (CSR) are no longer accessible.'}, {'type': 'SECONDARY', 'title': 'MI Size Normalized to Area at Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'OG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}], 'timeFrame': '48-72 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.'}, {'type': 'SECONDARY', 'title': 'Myocardial Perfusion at Coronary Angiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'OG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}], 'timeFrame': 'at completion of primary coronary intervention (PCI)', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.'}, {'type': 'SECONDARY', 'title': 'Infarct Transmurality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'OG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}], 'timeFrame': '48-72 hours and 4 months', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.'}, {'type': 'SECONDARY', 'title': 'Global & Regional Left Ventricular (LV) Function and LV Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'OG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}], 'timeFrame': '48-72 hours and 4 months', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.'}, {'type': 'SECONDARY', 'title': 'Change in Global LV Function and Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'OG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}], 'timeFrame': 'between 48-72 hours and 4 months', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.'}, {'type': 'SECONDARY', 'title': 'MI Size as a Fraction of LV Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'OG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}], 'timeFrame': '4 months', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.'}, {'type': 'SECONDARY', 'title': 'Resolution of ST Segment Elevation Compared With That Observed at Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'OG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}], 'timeFrame': '4 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.'}, {'type': 'SECONDARY', 'title': 'Troponin T Levels and CPK-MB Area Under the Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'OG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}], 'timeFrame': '48 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'OG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}], 'timeFrame': '4 months', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80 ppm'}, {'id': 'FG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80 ppm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Inclusion / exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '7 medical centers enrolled subjects. A total of 29 subjects were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide administered at 80ppm'}, {'id': 'BG001', 'title': 'Nitrogen Gas', 'description': 'Nitrogen Gas (Placebo) administered at 80ppm'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '11.71', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '12.41', 'groupId': 'BG001'}, {'value': '63.1', 'spread': '11.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Slow Enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2007-12-03', 'resultsFirstSubmitDate': '2010-08-03', 'studyFirstSubmitQcDate': '2007-12-03', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-08-03', 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size', 'timeFrame': '48-72 hours', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Myocardial Infarction (MI) Size at 48-72 Hours', 'timeFrame': '48-72 hours'}, {'measure': 'MI Size Normalized to Area at Risk', 'timeFrame': '48-72 hours'}, {'measure': 'Myocardial Perfusion at Coronary Angiography', 'timeFrame': 'at completion of primary coronary intervention (PCI)'}, {'measure': 'Infarct Transmurality', 'timeFrame': '48-72 hours and 4 months'}, {'measure': 'Global & Regional Left Ventricular (LV) Function and LV Mass', 'timeFrame': '48-72 hours and 4 months'}, {'measure': 'Change in Global LV Function and Mass', 'timeFrame': 'between 48-72 hours and 4 months'}, {'measure': 'MI Size as a Fraction of LV Size', 'timeFrame': '4 months'}, {'measure': 'Resolution of ST Segment Elevation Compared With That Observed at Enrollment', 'timeFrame': '4 hours'}, {'measure': 'Troponin T Levels and CPK-MB Area Under the Curve', 'timeFrame': '48 hours'}, {'measure': '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', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['INOT44', 'NOMI'], 'conditions': ['Acute Myocardial Infarction', 'ST Elevation MI', 'STEMI']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myocardial infarction and electrocardiographic evidence of ST elevation\n* No clinical evidence of congestive heart failure\n* 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\n* Greater than 18 years of age\n* Signed Institutional Review Board (IRB) approved informed consent\n\nExclusion Criteria:\n\n* Prior myocardial infarction\n* Requirement for urgent cardiac surgery\n* Previous coronary artery bypass graft (CABG) or primary coronary intervention (PCI)\n* Left bundle branch block\n* Heart block that is expected to require a temporary pacemaker for greater than 72 hours\n* Prior use of thrombolytic therapy for the current event\n* 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)\n* 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\n* 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.\n* Known or suspected aortic dissection.\n* Prior history of pulmonary disease requiring chronic oxygen therapy.\n* Pregnancy, lactating, and women of childbearing potential.\n* Medical problem likely to preclude completion of the study.\n* Use of investigational drugs or device within the 30 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT00568061', 'acronym': 'NOMI', 'briefTitle': 'Nitric Oxide in Myocardial Infarction Size', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size', 'orgStudyIdInfo': {'id': 'INOT 44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric oxide administered at 80 parts per million (ppm)', 'interventionNames': ['Drug: Nitric Oxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inhaled nitrogen gas (Placebo) administered at 80 ppm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nitric Oxide', 'type': 'DRUG', 'otherNames': ['INOmax®'], 'description': 'Nitric oxide for inhalation', 'armGroupLabels': ['Inhaled Nitric Oxide']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Nitrogen gas'], 'description': 'Nitrogen gas (placebo) for inhalation', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Providence Hospital', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Cardiac & Vascula Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospital', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jack D. Weiler Hospital', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'LeBauer Cardiology', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cardiovascular Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '84604', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Central Utah Imaging', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Virga Jesse Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': 'TGG 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'James Baldassarre, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mallinckrodt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mallinckrodt', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}