Viewing Study NCT01919450


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Study NCT ID: NCT01919450
Status: COMPLETED
Last Update Posted: 2018-08-16
First Post: 2013-07-25
Is Gene Therapy: True
Has Adverse Events: True

Brief Title: Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C430916', 'term': 'regadenoson'}, {'id': 'C000615479', 'term': 'Rubidium-82'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tbateman@cvit.com', 'phone': '816-531-2842', 'title': 'Timothy M. Bateman, MD', 'organization': 'Cardiovascular Imaging Technologies, LLC'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Adverse events were collected immediately post-informed consent and through the patient's entire visit to the imaging facility.", 'description': 'AEs were recorded on an Adverse Event (AE) log. The AE log consisted of: 1.) Description of event; 2.) Start and stop time of event; 3.) Severity of event; 4.) Likelihood that the event was related to the study drug; 5.) Relationship of event to other test procedures; 6.) Any treatment actions taken, and 7.) the final outcome.', 'eventGroups': [{'id': 'EG000', 'title': '10 Second Delay', 'description': 'A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 Minute Delay', 'description': 'A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '4 Minute Delay', 'description': 'A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '1 Minute Delay', 'description': 'A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Neck Pain', 'notes': '1 subject was admitted to ED 4 days post-study participation with chest/neck pain, predating study. Based upon symptoms and palpable left lateral neck discomfort, pt. was dismissed with a dx of musculoskeletal etiology.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '4 Minute Delay', 'description': 'A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.57', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 minutes', 'description': 'The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '2 Minute Delay', 'description': 'A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.93', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 mintues', 'description': 'The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '10 Second Delay', 'description': 'A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.34', 'spread': '.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 seconds', 'description': 'The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1 Minute Delay', 'description': 'A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.76', 'spread': '.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10 Second Delay', 'description': 'A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}, {'id': 'FG001', 'title': '2 Minute Delay', 'description': 'A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}, {'id': 'FG002', 'title': '4 Minute Delay', 'description': 'A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}, {'id': 'FG003', 'title': '1 Minute Delay', 'description': 'A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects with a low pretest likelihood for CAD based on gender, symptoms and recent (\\<90 days) normal-clinically-indicated TMET, exercise echocardiogram or exercise myocardial perfusion SPECT test were recruited for consent and participation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '10 Second Delay', 'description': 'A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}, {'id': 'BG001', 'title': '2 Minute Delay', 'description': 'A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}, {'id': 'BG002', 'title': '4 Minute Delay', 'description': 'A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}, {'id': 'BG003', 'title': '1 Minute Delay', 'description': 'A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.\n\nRegadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.\n\nRubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '51.3', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '53.1', 'spread': '9.6', 'groupId': 'BG002'}, {'value': '50.6', 'spread': '9.9', 'groupId': 'BG003'}, {'value': '51.9', 'spread': '11.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2013-07-25', 'resultsFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2013-08-08', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-07', 'studyFirstPostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)', 'timeFrame': '4 minutes', 'description': 'The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.'}, {'measure': 'Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson)', 'timeFrame': '2 mintues', 'description': 'The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.'}, {'measure': 'Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson)', 'timeFrame': '10 seconds', 'description': 'The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.'}, {'measure': 'Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson)', 'timeFrame': '1 minute', 'description': 'The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PET', 'Lexiscan', 'Regadenoson', 'Rubidium', 'Blood Flow Reserve', 'Myocardial Perfusion', 'Quantitated Myocardial Perfusion'], 'conditions': ['Myocardial Blood Flow Reserve']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the consistency of quantitative peak stress myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2 minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson) injection. It is anticipated that there will be no or minimal difference between the four delay times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent normal clinically-indicated exercise myocardial perfusion SPECT, treadmill maximal exercise test or exercise echocardiographic study\n* No change in symptoms between the exercise study and PET study\n* Capable of providing written informed consent\n* BMI 25-32 kg/m2\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Coronary Artery Calcium Score \\>25\n* Second and Third Degree Atrioventricular Node Block\n* Sinus Node Dysfunction\n* Recent Syncope of unknown etiology\n* Left ventricular hypertrophy per ECG or echocardiography\n* Slowed circulation times\n* Active wheezing or with acute asthmatic or bronchospastic attacks requiring changes in therapy within the past 30 days.\n* Patients that have experienced a previous hypersensitivity reaction thought to be related to Lexiscan'}, 'identificationModule': {'nctId': 'NCT01919450', 'briefTitle': 'Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiovascular Imaging Technologies'}, 'officialTitle': 'Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation', 'orgStudyIdInfo': {'id': '13-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10 Second Delay', 'description': 'A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.', 'interventionNames': ['Drug: Regadenoson', 'Radiation: Rubidium-82']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Minute Delay', 'description': 'A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.', 'interventionNames': ['Drug: Regadenoson', 'Radiation: Rubidium-82']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4 Minute Delay', 'description': 'A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.', 'interventionNames': ['Drug: Regadenoson', 'Radiation: Rubidium-82']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1 Minute Delay', 'description': 'A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.', 'interventionNames': ['Drug: Regadenoson', 'Radiation: Rubidium-82']}], 'interventions': [{'name': 'Regadenoson', 'type': 'DRUG', 'otherNames': ['Lexiscan'], 'description': 'Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.', 'armGroupLabels': ['1 Minute Delay', '10 Second Delay', '2 Minute Delay', '4 Minute Delay']}, {'name': 'Rubidium-82', 'type': 'RADIATION', 'otherNames': ['Cardio-Gen82'], 'description': 'Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.', 'armGroupLabels': ['1 Minute Delay', '10 Second Delay', '2 Minute Delay', '4 Minute Delay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital Imaging Center", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Timothy M Bateman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Imaging Technologies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Timothy M. Bateman, MD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Timothy M. Bateman, MD', 'investigatorAffiliation': 'Cardiovascular Imaging Technologies'}}}}