Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-01 @ 2:09 AM
Study NCT ID:
NCT01110395
Status:
COMPLETED
Last Update Posted:
2020-08-07
First Post:
2010-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phosphorous Magnetic Resonance Spectroscopy of Heart
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'groplerr@mir.wustl.edu', 'phone': '314-747-3877', 'title': 'Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There were no limitations or caveats'}}, 'adverseEventsModule': {'timeFrame': '1-2 days', 'eventGroups': [{'id': 'EG000', 'title': 'Post-Heart Transplant', 'description': 'Patients post heart transplant getting heart biopsy\n\nMR Spectroscopy: MR spectroscopy for myocardial lipid', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'An MR Spectroscopy Showing Signal to Noise Ratio to Determine the Level of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR Spectroscopy Post-Heart Transplant', 'description': 'Patients post heart transplant getting heart biopsy\n\nMR Spectroscopy: MR spectroscopy of myocardial'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '13.67', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean + SD', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.05', 'pValueComment': 'Bland Altman', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.96', 'estimateComment': 'We have provided all the information that is available to us. The PI has left the institution and we are unable to contact him. We have no further data to correct the errors.', 'groupDescription': 'We are unable to provide any further data that has been requested. We have supplied all the data that we can possibly provide because the PI has left the institution and we are unable to contact him. We have no other data.', 'statisticalMethod': 'mean + SD', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Bland Altman', 'nonInferiorityComment': 'Bland and Altman', 'otherAnalysisDescription': 'There are no other statistical analysis. We have provided all the information that is available to us. We have no other data available to us because the PI has left the institution and we are unable to contact him.'}, {'pValue': '<0.05', 'groupIds': ['OG000'], 'statisticalMethod': 'Mean + SD', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1-2 days', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transplant', 'description': 'Patients with post-OHT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients recruited from heart transplant clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Heart Failure', 'description': 'Magnetic Resonance Spectroscopy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2010-04-22', 'resultsFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2010-04-22', 'lastUpdatePostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-22', 'studyFirstPostDateStruct': {'date': '2010-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'An MR Spectroscopy Showing Signal to Noise Ratio to Determine the Level of Heart Failure', 'timeFrame': '1-2 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Left Ventricular Dysfunction']}, 'referencesModule': {'references': [{'pmid': '11736631', 'type': 'BACKGROUND', 'citation': 'Lipskaya TY. Mitochondrial creatine kinase: properties and function. Biochemistry (Mosc). 2001 Oct;66(10):1098-111. doi: 10.1023/a:1012428812780.'}, {'pmid': '8873665', 'type': 'BACKGROUND', 'citation': 'Nascimben L, Ingwall JS, Pauletto P, Friedrich J, Gwathmey JK, Saks V, Pessina AC, Allen PD. Creatine kinase system in failing and nonfailing human myocardium. Circulation. 1996 Oct 15;94(8):1894-901. doi: 10.1161/01.cir.94.8.1894.'}, {'pmid': '10400912', 'type': 'BACKGROUND', 'citation': 'De Sousa E, Veksler V, Minajeva A, Kaasik A, Mateo P, Mayoux E, Hoerter J, Bigard X, Serrurier B, Ventura-Clapier R. Subcellular creatine kinase alterations. Implications in heart failure. Circ Res. 1999 Jul 9;85(1):68-76. doi: 10.1161/01.res.85.1.68.'}, {'pmid': '7882493', 'type': 'BACKGROUND', 'citation': 'Nascimben L, Friedrich J, Liao R, Pauletto P, Pessina AC, Ingwall JS. Enalapril treatment increases cardiac performance and energy reserve via the creatine kinase reaction in myocardium of Syrian myopathic hamsters with advanced heart failure. Circulation. 1995 Mar 15;91(6):1824-33. doi: 10.1161/01.cir.91.6.1824.'}], 'seeAlsoLinks': [{'url': 'http://wileyonlinelibrary.com/journal/nbm', 'label': 'Nuclear Medicine in Biomedicine'}]}, 'descriptionModule': {'briefSummary': 'Heart needs constant supply of energy to continue working. Phosphorus magnetic resonance spectroscopy allows us to measure energy produced in the heart. The purpose of this study is to determine if the energy production is reduced in failing heart.', 'detailedDescription': 'We will use non-invasive phosphorus magnetic resonance spectroscopy technique to measure creatine kinase (CK) flux in failing heart. The studies will be done on Siemens 3.0T human system. We will recruit subjects with LV dysfunction due to prior anterior wall myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with left ventricular dysfunction\n\nExclusion Criteria:\n\n* Age \\< 18, pregnant, history of excessive alcohol use, or any condition (e.g. claustrophobia, a pacemaker) that would prevent him/her from completing the magnetic resonance spectroscopy study'}, 'identificationModule': {'nctId': 'NCT01110395', 'briefTitle': 'Phosphorous Magnetic Resonance Spectroscopy of Heart', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': '31P Magnetic Resonance Spectroscopy of Heart', 'orgStudyIdInfo': {'id': '09-0533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MR Spectroscopy Post-Heart Transplant', 'description': 'Patients post heart transplant getting heart biopsy', 'interventionNames': ['Diagnostic Test: MR Spectroscopy']}], 'interventions': [{'name': 'MR Spectroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'MR spectroscopy of myocardial', 'armGroupLabels': ['MR Spectroscopy Post-Heart Transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Adil Bashir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}