Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00924118
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2009-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sodium Nitrite in Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012977', 'term': 'Sodium Nitrite'}], 'ancestors': [{'id': 'D009573', 'term': 'Nitrites'}, {'id': 'D009608', 'term': 'Nitrous Acid'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sschulma@jhmi.edu', 'phone': '4109557378', 'title': 'Steven P. Schulman, MD', 'phoneExt': '410', 'organization': 'Johns Hopkins Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The primary and secondary outcomes of this study were limited by too few subjects undergoing these studies.'}}, 'adverseEventsModule': {'timeFrame': '7 years', 'eventGroups': [{'id': 'EG000', 'title': 'Sodium Nitrite', 'description': 'Dose escalation of sodium nitrite.\n\nSodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Open Control', 'description': 'Subjects randomized to open control will receive no experimental therapy.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Hypotension', 'notes': 'Transient hypotension developed in 4 subjects.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'Two subjects developed nausea during study drug infusion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Nitrite', 'description': 'Dose escalation of sodium nitrite.\n\nSodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.'}, {'id': 'OG001', 'title': 'Open Control', 'description': 'Subjects randomized to open control will receive no experimental therapy.'}], 'timeFrame': '4-5 days from enrollment', 'description': 'Measured as percentage of left ventricle', 'reportingStatus': 'POSTED', 'populationDescription': 'Sestamibi imaging proved impossible to obtain emergently and therefore no data was collected.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Infarct Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Nitrite', 'description': 'Dose escalation of sodium nitrite.\n\nSodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.'}, {'id': 'OG001', 'title': 'Open Control', 'description': 'Subjects randomized to open control will receive no experimental therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '17'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '31'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-5 days following enrollment', 'description': 'Left ventricular infarct size by Magnetic Resonance Imaging (MRI). Calculated percentage of the left ventricular mass by MRI that has undergone infarction.', 'unitOfMeasure': 'infarct percentage of left ventricle', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 2 participants from each arm underwent MRI imaging. Too few subjects underwent MRI imaging to make a statistical comparison. Only those where data was obtained has been reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sodium Nitrite', 'description': 'Dose escalation of sodium nitrite.\n\nSodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.'}, {'id': 'FG001', 'title': 'Open Control', 'description': 'Subjects randomized to open control will receive no experimental therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sodium Nitrite', 'description': 'Dose escalation of sodium nitrite.\n\nSodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.'}, {'id': 'BG001', 'title': 'Open Control', 'description': 'Subjects randomized to open control will receive no experimental therapy.'}, {'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': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '76'}, {'value': '59.2', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '72'}, {'value': '59.4', 'groupId': 'BG002', 'lowerLimit': '44', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-11', 'studyFirstSubmitDate': '2009-06-17', 'resultsFirstSubmitDate': '2017-07-28', 'studyFirstSubmitQcDate': '2009-06-17', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-25', 'studyFirstPostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.', 'timeFrame': '4-5 days from enrollment', 'description': 'Measured as percentage of left ventricle'}], 'secondaryOutcomes': [{'measure': 'Left Ventricular Infarct Size', 'timeFrame': '4-5 days following enrollment', 'description': 'Left ventricular infarct size by Magnetic Resonance Imaging (MRI). Calculated percentage of the left ventricular mass by MRI that has undergone infarction.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute myocardial infarction', 'Reperfusion injury', 'Nitric oxide'], 'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '18519850', 'type': 'BACKGROUND', 'citation': 'Gonzalez FM, Shiva S, Vincent PS, Ringwood LA, Hsu LY, Hon YY, Aletras AH, Cannon RO 3rd, Gladwin MT, Arai AE. Nitrite anion provides potent cytoprotective and antiapoptotic effects as adjunctive therapy to reperfusion for acute myocardial infarction. Circulation. 2008 Jun 10;117(23):2986-94. doi: 10.1161/CIRCULATIONAHA.107.748814. Epub 2008 Jun 2.'}, {'pmid': '15841216', 'type': 'BACKGROUND', 'citation': 'Duranski MR, Greer JJ, Dejam A, Jaganmohan S, Hogg N, Langston W, Patel RP, Yet SF, Wang X, Kevil CG, Gladwin MT, Lefer DJ. Cytoprotective effects of nitrite during in vivo ischemia-reperfusion of the heart and liver. J Clin Invest. 2005 May;115(5):1232-40. doi: 10.1172/JCI22493. Epub 2005 Apr 14.'}, {'pmid': '17495223', 'type': 'BACKGROUND', 'citation': 'Rassaf T, Flogel U, Drexhage C, Hendgen-Cotta U, Kelm M, Schrader J. Nitrite reductase function of deoxymyoglobin: oxygen sensor and regulator of cardiac energetics and function. Circ Res. 2007 Jun 22;100(12):1749-54. doi: 10.1161/CIRCRESAHA.107.152488. Epub 2007 May 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the intravenous infusion of sodium nitrite safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction resulting in improved left ventricular function.', 'detailedDescription': 'Despite reperfusion therapies, significant myocardial injury continues to occur from ischemic-reperfusion injury. Studies in animal models of acute myocardial infarction suggest that an infusion of sodium nitrite, which is nonenzymatically converted to nitric oxide in the setting of ischemia, significantly reduces ischemia-reperfusion injury resulting in smaller infarcts and improved left ventricular function. The objectives of this phase 2 trial are to determine the tolerability and safety of a 48-hour infusion of sodium nitrite in patients with an acute ST-segment elevation myocardial infarction receiving percutaneous coronary intervention. The efficacy of a 48-hour infusion of sodium nitrite will be determined by noninvasive imaging to determine infarct size and left ventricular function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute ST segment elevation myocardial infarction\n* Eligible for percutaneous coronary intervention\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* Cardiac arrest\n* Prior infarct in the infarct related artery\n* Hemoglobinopathy, Glucose-6 Phosphate Dehydrogenase (G6PD) deficiency'}, 'identificationModule': {'nctId': 'NCT00924118', 'briefTitle': 'Sodium Nitrite in Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Safety and Efficacy Evaluation of Sodium Nitrite Injection for the Prevention of Ischemia-Reperfusion Injury Associated With Acute Myocardial Infarction.', 'orgStudyIdInfo': {'id': 'NA_00023049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium Nitrite', 'description': 'Dose escalation of sodium nitrite.', 'interventionNames': ['Drug: Sodium Nitrite']}, {'type': 'NO_INTERVENTION', 'label': 'Open Control', 'description': 'Standard therapy'}], 'interventions': [{'name': 'Sodium Nitrite', 'type': 'DRUG', 'description': 'Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.', 'armGroupLabels': ['Sodium Nitrite']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Steven P Schulman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hope Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}