Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT02933034
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'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': 'C483739', 'term': 'EVP 1001-1'}, {'id': 'D019786', 'term': 'Gadolinium DTPA'}], 'ancestors': [{'id': 'D004369', 'term': 'Pentetic Acid'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'phillip@stanford.edu', 'phone': '(650) 498-8008', 'title': 'Phillip C. Yang', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study did not meet its planned sample size of 70 patients.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline to end of study (average 616 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as a reagent); and DEMRI (gadolinium 0.2 mmol/kg as a reagent).', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 14, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lip numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mild discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mild jaw pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mild weakness of feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Infarct Size of MEMRI Versus DEMRI Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'MEMRI', 'categories': [{'measurements': [{'value': '12.2', 'spread': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'DEMRI', 'categories': [{'measurements': [{'value': '18.9', 'spread': '11.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'groupDescription': 'Comparison of infarct size using MEMRI versus DEMRI scan', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day of MEMRI and DEMRI scans (up to 3 hours per scan, performed on the same day or up to 7 days apart)', 'description': 'MEMRI is an assessment of non-viable myocardial tissue and evaluates core infarct size. DEMRI is an assessment of fibrotic tissue and evaluates the total infarct size. The difference between these two measurements evaluates the size of peri-infarct region consisting of mixed components of injured but viable cardiomyocytes and fibrosis.', 'unitOfMeasure': 'percentage of left ventricle', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '121.8', 'spread': '16.4', 'groupId': 'OG000'}]}]}, {'title': 'During MRI', 'categories': [{'measurements': [{'value': '160.9', 'spread': '24.4', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '124.4', 'spread': '18.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before, during, and after MEMRI scan (up to 3 hours)', 'description': 'Systolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 90-120 mmHg.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '71.8', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'During MRI', 'categories': [{'measurements': [{'value': '92.6', 'spread': '10.8', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '66.2', 'spread': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before,during, and after MEMRI scan (up to 3 hours)', 'description': 'Diastolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60-80 mmHg.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '66.3', 'spread': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'During MRI', 'categories': [{'measurements': [{'value': '82.8', 'spread': '15.1', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '66.2', 'spread': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before,during, and after MEMRI scan (up to 3 hours)', 'description': 'Heart rate during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60 and 100 beats per minute.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '414.7', 'spread': '40.1', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '412.6', 'spread': '38.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'QT interval during MEMRI scan as a measure of manganese contrast reagent safety. QT is a measurement of heart function that is dependent on heart rate, so QTc is mainly used for diagnosis rather than QT. Normal reference range was considered to be 360-450 milliseconds for this study.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Corrected QT (QTc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '435.7', 'spread': '34.5', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '440.5', 'spread': '37.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'Corrected QT (QTc) interval during MEMRI scan as a measure of manganese contrast reagent safety. QTc is a measurement of heart function and is mainly used for diagnosis rather than QT, because QT is dependent on heart rate. Normal reference range was considered to be 360-450 milliseconds for this study.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '37.8', 'spread': '18.4', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '35.1', 'spread': '12.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'ALT levels during MEMRI scan as a measure of manganese contrast reagent safety. ALT is a measurement of liver function. Normal reference range was considered to be \\<60 U/L for this study.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.1', 'spread': '12.4', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '25.4', 'spread': '9.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'AST levels during MEMRI scan as a measure of manganese contrast reagent safety. AST is a measurement of liver function. Normal reference range was considered to be \\<40 U/L for this study.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Alkaline Phosphatase (ALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '80.8', 'spread': '21.9', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '79.8', 'spread': '26.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'ALP levels during MEMRI scan as a measure of manganese contrast reagent safety. ALP is a measurement of liver function. Normal reference range was considered to be \\<40-130 U/L for this study.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'Total bilirubin levels during MEMRI scan as a measure of manganese contrast reagent safety. Total bilirubin is a measurement of liver function. Normal reference range was considered to be \\<1.4 mg/dL for this study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.23', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '1.10', 'spread': '0.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'Creatinine levels during MEMRI scan as a measure of manganese contrast reagent safety. Creatinine is a measurement of kidney function. Normal reference range was considered to be 0.50-1.20 mg/dL for this study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Estimated Glomerular Filtration Rate (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'classes': [{'title': 'Pre MRI', 'categories': [{'measurements': [{'value': '75.4', 'spread': '20.5', 'groupId': 'OG000'}]}]}, {'title': 'Post MRI', 'categories': [{'measurements': [{'value': '70.5', 'spread': '16.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'eGFR levels during MEMRI scan as a measure of manganese contrast reagent safety. eGFR is a measurement of kidney function. Normal reference range was considered to be \\>60 ml/min/1.73m\\^2 for this study.', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both MEMRI and DEMRI scans are included in the analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: manganese-enhanced MRI (MEMRI; manganese 0.28 mL/kg as reagent); and delayed-enhanced MRI (DEMRI; gadolinium 0.2 mmol/kg as reagent).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Received Both MEMRI and DEMRI Scans', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Coronary Disease Patients', 'description': 'Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '7.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'South Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Latino', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants who had both MEMRI and DEMRI scans were considered evaluable for baseline characteristics'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-21', 'size': 518316, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-28T17:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-01', 'studyFirstSubmitDate': '2016-10-11', 'resultsFirstSubmitDate': '2020-02-01', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-01', 'studyFirstPostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infarct Size of MEMRI Versus DEMRI Scans', 'timeFrame': 'Day of MEMRI and DEMRI scans (up to 3 hours per scan, performed on the same day or up to 7 days apart)', 'description': 'MEMRI is an assessment of non-viable myocardial tissue and evaluates core infarct size. DEMRI is an assessment of fibrotic tissue and evaluates the total infarct size. The difference between these two measurements evaluates the size of peri-infarct region consisting of mixed components of injured but viable cardiomyocytes and fibrosis.'}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'Before, during, and after MEMRI scan (up to 3 hours)', 'description': 'Systolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 90-120 mmHg.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Before,during, and after MEMRI scan (up to 3 hours)', 'description': 'Diastolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60-80 mmHg.'}, {'measure': 'Heart Rate', 'timeFrame': 'Before,during, and after MEMRI scan (up to 3 hours)', 'description': 'Heart rate during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60 and 100 beats per minute.'}, {'measure': 'QT Interval', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'QT interval during MEMRI scan as a measure of manganese contrast reagent safety. QT is a measurement of heart function that is dependent on heart rate, so QTc is mainly used for diagnosis rather than QT. Normal reference range was considered to be 360-450 milliseconds for this study.'}, {'measure': 'Corrected QT (QTc)', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'Corrected QT (QTc) interval during MEMRI scan as a measure of manganese contrast reagent safety. QTc is a measurement of heart function and is mainly used for diagnosis rather than QT, because QT is dependent on heart rate. Normal reference range was considered to be 360-450 milliseconds for this study.'}, {'measure': 'Alanine Aminotransferase (ALT)', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'ALT levels during MEMRI scan as a measure of manganese contrast reagent safety. ALT is a measurement of liver function. Normal reference range was considered to be \\<60 U/L for this study.'}, {'measure': 'Aspartate Aminotransferase (AST)', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'AST levels during MEMRI scan as a measure of manganese contrast reagent safety. AST is a measurement of liver function. Normal reference range was considered to be \\<40 U/L for this study.'}, {'measure': 'Alkaline Phosphatase (ALP)', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'ALP levels during MEMRI scan as a measure of manganese contrast reagent safety. ALP is a measurement of liver function. Normal reference range was considered to be \\<40-130 U/L for this study.'}, {'measure': 'Total Bilirubin', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'Total bilirubin levels during MEMRI scan as a measure of manganese contrast reagent safety. Total bilirubin is a measurement of liver function. Normal reference range was considered to be \\<1.4 mg/dL for this study.'}, {'measure': 'Creatinine', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'Creatinine levels during MEMRI scan as a measure of manganese contrast reagent safety. Creatinine is a measurement of kidney function. Normal reference range was considered to be 0.50-1.20 mg/dL for this study.'}, {'measure': 'Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Before and after MEMRI scan (up to 3 hours)', 'description': 'eGFR levels during MEMRI scan as a measure of manganese contrast reagent safety. eGFR is a measurement of kidney function. Normal reference range was considered to be \\>60 ml/min/1.73m\\^2 for this study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ISCHEMIC OR CORONARY HEART DISEASE', 'MYOCARDIAL INFARCTION', 'MAGNETIC RESONANCE IMAGING', 'DELAYED GADOLINIUM ENHANCEMENT MRI', 'MANGANESE-ENHANCED MRI', 'INFARCT VOLUME/SIZE', 'ALL CAUSE MORTALITY', 'VENTRICULAR ARRHYTHMIAS'], 'conditions': ['ISCHEMIC CARDIOMYOPATHY']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerance of a new intravenous diagnostic agent, SeeMore or EVP 1001-1, in patients with Cardiovascular Disease (MEMRI scan). The initial phase of this study, NCT01989195 enrolling a total of 6 patients, has been closed. This second phase adds 10 patients in a safety cohort and 60 additional patients for a total of 70 patients.', 'detailedDescription': 'This is an open-label, baseline-controlled study to be conducted. Adult male or nonpregnant female patients who have been referred for evaluation of dilated cardiomyopathy, ischemic cardiomyopathy, non-ischemic cardiomyopathy, atrial arrhythmia and also patients who have received stem cell therapy related to both ischemic and dilated cardiomyopathy (under different trials) will be recruited. An initial cohort study of 6 patients to conduct safety evaluation was conducted before proceeding with 60 additional patients. In the initial cohort, a patient was dosed based on the Phase 1 and 2 clinical trial data evaluation completed by Eagle Vision Pharmaceutical, Inc. Subjects were excluded if they had received an investigational device within 30 days prior to administration of EVP1001-1; had a history of drug abuse or alcoholism; were taking a digitalis preparation; had a history of torsades; had New York Heart Association (NYHA) Grade IV heart failure; had abnormal liver function tests or a history of liver disease; had uncontrolled hypertension; had abnormal calcium, potassium or hemoglobin values at baseline; if they develop a cardiac arrhythmia prior to or during either of the exercise tests-- EVP1001-1 was not administered. The same parameters will apply to the new group of subjects.\n\nPrior to entry into this study, all subjects will sign an Informed Consent and will undergo a physical examination including medical history, details regarding their cardiac history, prescription and over-the-counter drug questionnaire, vital signs, electrocardiogram (ECG), evaluation of the major organ systems, hematology, serum chemistries, and urinalysis. In addition, female subjects will undergo a serum pregnancy test.\n\nStarting 30 minutes before the cardiac MRI scan (CMR), the subjects will take a 16 mg tablet of ondansetron by mouth. CMR imaging will subsequently take place and then EVP1001-1 will then be administered approximately 15 minutes into the scan for contrast enhanced images. EVP1001-1 will be administered intravenously over approximately one minute. The subjects will each receive 0.28 mL/kg of EVP 1001-1. All subjects will be monitored closely from before ondansetron administration until their discharge from the imaging center. Following MEMRI, delayed-enhanced MRI (DEMRI scan) is performed using 0.2 mmol/kg.\n\nWe will compare the two different contrast enhanced images (EVP1001-1 vs gadolinium (GD)) in determining the non-viable (infarct core), peri-infarct, and total infarct size of myocardial tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects to be entered must:\n\n* be at least 18 years of age.\n* if female, be nonpregnant as evidenced by a serum pregnancy test and using a medically-approved method of birth control, or post-menopausal or surgically sterile\n* provide written informed consent after having received oral and written information about the study\n* be in stable health based on medical history, examination and tests\n\nExclusion Criteria:\n\nhave a positive pregnancy test (females)\n\n* received an investigational drug or device within 30 days prior to administration of SeeMore\n* have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor blockers\n* have a history of drug abuse or alcoholism\n* are taking a digitalis preparation or calcium channel blocker\n* have a history of torsades or prolonged QT/QTc interval\n* have NYHA Grade IV heart failure\n* have abnormal liver function tests or a history of liver disease\n* have uncontrolled hypertension (Systolic Blood Pressure \\> 140 or Diastolic BP \\> 90 consistently at baseline)\n* have abnormal baseline potassium or calcium values or hemoglobin less than 10 g/dl\n* are noncompliant or otherwise unlikely to perform as required by the protocol\n* have pretest likelihood of CAD for which the requisite number of subjects have been entered\n* develop an arrhythmia prior to or during either of the exercise tests; SeeMore should not be administered.'}, 'identificationModule': {'nctId': 'NCT02933034', 'briefTitle': 'Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury', 'orgStudyIdInfo': {'id': '28508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coronary Disease', 'description': 'Participant receive 2 cardiac MRI procedures: MEMRI and DEMRI.', 'interventionNames': ['Drug: Manganese-enhanced MRI contrast reagent', 'Drug: Gadolinium-enhanced MRI contrast reagent']}], 'interventions': [{'name': 'Manganese-enhanced MRI contrast reagent', 'type': 'DRUG', 'otherNames': ['EVP 1001-1'], 'description': 'MRI using manganese-enhanced MRI contrast reagent (manganese 0.28 mL/kg).', 'armGroupLabels': ['Coronary Disease']}, {'name': 'Gadolinium-enhanced MRI contrast reagent', 'type': 'DRUG', 'otherNames': ['GD-DTPA'], 'description': 'MRI using gadolinium-enhanced MRI contrast reagent (gadolinium 0.2 mmol/kg).', 'armGroupLabels': ['Coronary Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Phillip C Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'General Electric', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Phillip C. Yang, MD', 'investigatorAffiliation': 'Stanford University'}}}}