Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-27 @ 9:40 AM
Study NCT ID:
NCT01109992
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2010-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'C430916', 'term': 'regadenoson'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sdorbala@partners.org', 'phone': '617-732-6215', 'title': 'Sharmila Dorbala', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected on the day of the research study which was in week 2 for most patients.', 'eventGroups': [{'id': 'EG000', 'title': 'Regadenoson (Lexiscan)', 'description': 'Regadenoson Rubidium-82 Positron Emission Tomography\n\nRegadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exercise + Regadenoson (Lexiscan)', 'description': 'Exercise plus Regadenoson (Lexiscan) Rubidium-82 Positron Emission Tomography\n\nExercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety and Tolerability of Combined Exercise and Regadenoson Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson (Lexiscan)', 'description': 'Regadenoson Rubidium-82 Positron Emission Tomography\n\nRegadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography.'}, {'id': 'OG001', 'title': 'Exercise + Regadenoson (Lexercise)', 'description': 'Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography\n\nExercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography'}], 'classes': [{'title': 'Count of ischemic ECG changes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Count of subjects systolic blood pressure decrease', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Count of subjects with abnormal troponin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of the research scan during the stress test', 'description': '1. Count of subjects with ischemic ECG changes is reported\n2. Count of subjects with systolic blood pressure decrease \\> 20 mm Hg is reported\n3. Count of subjects with abnormal serum troponin T levels is reported\n4. Radiation dose to the staff will be measured using personal dosimeters after the Lexiscan as well as the Lexercise PET study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Radiation dose to staff was not measured due to logistical difficulties.Three subjects had blood pressure changes in the Regadenoson (Lexiscan) arm; 3 subjects showed ischemic ECG changes in the exercise + regadenoson (Lexercise) arm; and, none of the subjects showed abnormal troponin levels.'}, {'type': 'SECONDARY', 'title': 'Image Quality: Heart to Liver Ratio of Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson (Lexiscan)', 'description': 'Regadenoson Rubidium-82 Positron Emission Tomography\n\nRegadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography.\n\nNo adverse events'}, {'id': 'OG001', 'title': 'Exercise + Regadenoson (Lexiscan)', 'description': 'Exercise plus Regadenoson (Lexiscan) Rubidium-82 Positron Emission Tomography\n\nExercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography\n\nNo adverse events'}], 'classes': [{'title': 'Stress Scan 1', 'categories': [{'measurements': [{'value': '1.23', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Stress Scan 2', 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 (day of the clinical scan), and Week 2 (day of the research scan)', 'description': 'Sub-diaphragmatic activity: Heart to Liver Ratio was measured on the rubidium-82 and N-13 ammonia scans. Since this measure is a ratio it has no units. Mean and Standard Deviation of Ratio is reported for each group.\n\nThis was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.', 'unitOfMeasure': 'mean ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson (Lexiscan)', 'description': 'Regadenoson Rubidium-82 Positron Emission Tomography\n\nRegadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography.\n\nNo adverse events'}, {'id': 'OG001', 'title': 'Exercise + Regadenoson (Lexercise)', 'description': 'Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography\n\nExercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography\n\nNo adverse events'}], 'classes': [{'title': 'Stress 1 Scan', 'categories': [{'measurements': [{'value': '58', 'spread': '15', 'groupId': 'OG000'}, {'value': '60', 'spread': '14', 'groupId': 'OG001'}]}]}, {'title': 'Stress 2 Scan', 'categories': [{'measurements': [{'value': '59', 'spread': '15', 'groupId': 'OG000'}, {'value': '62', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 (day of the clinical scan), and Week 2 (day of the research scan)', 'description': 'Left ventricular ejection fraction (LVEF) at stress was measured at Stress scan 1 (regadenoson) and Stress scan 2 (regadenoson or exercise + regadenoson).\n\nThis was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.', 'unitOfMeasure': 'percentage of LVEF', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Stress Myocardial Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson (Lexiscan)', 'description': 'Regadenoson Rubidium-82 Positron Emission Tomography\n\nRegadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography.\n\nNo adverse events'}, {'id': 'OG001', 'title': 'Exercise + Regadenoson (Lexiscan)', 'description': 'Exercise plus Regadenoson (Lexiscan) Rubidium-82 Positron Emission Tomography\n\nExercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography\n\nNo adverse events'}], 'classes': [{'title': 'Stress 1 Scan', 'categories': [{'measurements': [{'value': '1.82', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Stress 2 Scan', 'categories': [{'measurements': [{'value': '1.85', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 (day of the clinical scan), and Week 2 (day of the research scan)', 'description': 'Myocardial Blood Flow Measured at Peak Hyperemia With Regadenoson or Immediately After Exercise + Regadenoson This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.', 'unitOfMeasure': 'mL/gm/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Myocardial blood flow could not be accurately measured in one subject from each arm. Therefore we report information on 10/11 subjects in Regadenoson arm and 29/30 subjects in the Exercise + Regadenoson arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Regadenoson', 'description': 'Regadenoson Rubidium-82 Positron Emission Tomography\n\nRegadenoson Rubidium-82 Positron Emission Tomography'}, {'id': 'FG001', 'title': 'Exercise + Regadenoson', 'description': 'Exercise plus Regadenoson Rubidium-82 Positron Emission Tomography\n\nExercise plus Regadenoson: Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Subjects screened', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Subjects Enrolled', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Movement during rest scan.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '43 subjects consented for the study and 41 subjects completed the study. One subject did not come for the study procedures. One subject could not cooperate with imaging and was moving during the rest scan. Regadenoson scan was not performed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Regadenoson', 'description': 'Regadenoson Rubidium-82 Positron Emission Tomography\n\nRegadenoson: Regadenoson Rubidium-82 Positron Emission Tomography'}, {'id': 'BG001', 'title': 'Exercise + Regadenoson', 'description': 'Exercise plus Regadenoson Rubidium-82 Positron Emission Tomography\n\nExercise plus Regadenoson: Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '11', 'groupId': 'BG000'}, {'value': '54', 'spread': '15', 'groupId': 'BG001'}, {'value': '57', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-12', 'size': 1019871, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-14T12:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-27', 'studyFirstSubmitDate': '2010-04-16', 'resultsFirstSubmitDate': '2018-06-14', 'studyFirstSubmitQcDate': '2010-04-22', 'lastUpdatePostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-27', 'studyFirstPostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of Combined Exercise and Regadenoson Stress', 'timeFrame': 'Day of the research scan during the stress test', 'description': '1. Count of subjects with ischemic ECG changes is reported\n2. Count of subjects with systolic blood pressure decrease \\> 20 mm Hg is reported\n3. Count of subjects with abnormal serum troponin T levels is reported\n4. Radiation dose to the staff will be measured using personal dosimeters after the Lexiscan as well as the Lexercise PET study.'}], 'secondaryOutcomes': [{'measure': 'Image Quality: Heart to Liver Ratio of Counts', 'timeFrame': 'Week 1 (day of the clinical scan), and Week 2 (day of the research scan)', 'description': 'Sub-diaphragmatic activity: Heart to Liver Ratio was measured on the rubidium-82 and N-13 ammonia scans. Since this measure is a ratio it has no units. Mean and Standard Deviation of Ratio is reported for each group.\n\nThis was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.'}, {'measure': 'Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET', 'timeFrame': 'Week 1 (day of the clinical scan), and Week 2 (day of the research scan)', 'description': 'Left ventricular ejection fraction (LVEF) at stress was measured at Stress scan 1 (regadenoson) and Stress scan 2 (regadenoson or exercise + regadenoson).\n\nThis was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.'}, {'measure': 'Peak Stress Myocardial Blood Flow', 'timeFrame': 'Week 1 (day of the clinical scan), and Week 2 (day of the research scan)', 'description': 'Myocardial Blood Flow Measured at Peak Hyperemia With Regadenoson or Immediately After Exercise + Regadenoson This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'exercise', 'regadenoson', 'positron emission tomography'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '15837254', 'type': 'BACKGROUND', 'citation': 'Chow BJ, Ananthasubramaniam K, dekemp RA, Dalipaj MM, Beanlands RS, Ruddy TD. Comparison of treadmill exercise versus dipyridamole stress with myocardial perfusion imaging using rubidium-82 positron emission tomography. J Am Coll Cardiol. 2005 Apr 19;45(8):1227-34. doi: 10.1016/j.jacc.2005.01.016.'}, {'pmid': '17372188', 'type': 'BACKGROUND', 'citation': 'Di Carli MF, Hachamovitch R. New technology for noninvasive evaluation of coronary artery disease. Circulation. 2007 Mar 20;115(11):1464-80. doi: 10.1161/CIRCULATIONAHA.106.629808. No abstract available.'}, {'pmid': '12975245', 'type': 'BACKGROUND', 'citation': "Klocke FJ, Baird MG, Lorell BH, Bateman TM, Messer JV, Berman DS, O'Gara PT, Carabello BA, Russell RO Jr, Cerqueira MD, St John Sutton MG, DeMaria AN, Udelson JE, Kennedy JW, Verani MS, Williams KA, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Society for Nuclear Cardiology. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines for the Clinical Use of Cardiac Radionuclide Imaging). Circulation. 2003 Sep 16;108(11):1404-18. doi: 10.1161/01.CIR.0000080946.42225.4D. No abstract available."}, {'pmid': '16412870', 'type': 'BACKGROUND', 'citation': 'Chow BJ, Beanlands RS, Lee A, DaSilva JN, deKemp RA, Alkahtani A, Ruddy TD. Treadmill exercise produces larger perfusion defects than dipyridamole stress N-13 ammonia positron emission tomography. J Am Coll Cardiol. 2006 Jan 17;47(2):411-6. doi: 10.1016/j.jacc.2005.09.027.'}, {'pmid': '17314342', 'type': 'BACKGROUND', 'citation': 'Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007 Feb 22;356(8):830-40. doi: 10.1056/NEJMra061889. No abstract available.'}, {'pmid': '16085581', 'type': 'BACKGROUND', 'citation': 'El Fakhri G, Sitek A, Guerin B, Kijewski MF, Di Carli MF, Moore SC. Quantitative dynamic cardiac 82Rb PET using generalized factor and compartment analyses. J Nucl Med. 2005 Aug;46(8):1264-71.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-center study of subjects undergoing clinically indicated heart scans for evaluation of known or suspected heart disease. We will also include 10 healthy subjects without known heart disease. We would like to study stress testing of the heart using exercise and a medication called regadenoson. Imaging of the heart will be performed.', 'detailedDescription': 'Regadenoson is stress agent approved by the FDA for use with myocardial perfusion imaging with technetium-99m single photon emission computed tomography (SPECT) in patients that are unable to exercise adequately. We would like to study Regadenoson in conjunction with Exercise Rubidium-82 positron emission tomography myocardial perfusion imaging (PET MPI). Regadenoson is not approved by FDA for use with Rubidium-82 PET MPI. Also, we would like to study a novel stress protocol of Regadenoson combined with symptom limited exercise stress (not FDA approved).\n\nThe objectives of this study are to assess the tolerability and safety of combined symptom limited exercise stress test with Lexiscan (Lexercise PET) compared to Lexiscan alone (Lexiscan PET), to assess image quality of Lexercise compared to Lexiscan PET and to compare relative and absolute myocardial perfusion imaging with Lexercise compared to Lexiscan PET to identify CAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Clinically indicated N-13 ammonia PET study or ten healthy volunteers\n* Known coronary artery disease (prior percutaneous coronary intervention, prior coronary artery bypass surgery or Q wave MI on ECG) or intermediate to high pretest likelihood of CAD\n* Able to exercise on a treadmill\n* Able and willing to provide informed consent to participate in the study\n\nExclusion Criteria:\n\n* Contraindications to exercise stress testing such as, unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure \\< 90 or \\> 200 mmHg, respectively), or \\> 1st degree atrioventricular block in the absence of a functioning pacemaker.\n* Subject requires emergent cardiac medical intervention or catheterization after the clinical study.\n* Documented myocardial infarction (MI) ≤ 30 days prior to enrollment.\n* History of percutaneous coronary intervention (PCI) ≤ 4weeks prior to enrollment.\n* History of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment.\n* History of heart transplantation.\n* Allergy or intolerance to aminophylline or regadenoson\n* Known severe or oxygen dependent bronchoconstrictive or bronchospastic lung disease \\[e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.\\].\n* Severe LV dysfunction, with ejection fraction of \\< 30%\n* Serious non-cardiac medical illness (e.g., disseminated malignancy, severe neurological dysfunction at time of baseline PET study) or a social situation which will preclude research study participation\n* History of Seizures.'}, 'identificationModule': {'nctId': 'NCT01109992', 'acronym': 'IDEALPET', 'briefTitle': 'Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Integrated Dual Exercise and Lexiscan PET: IDEAL PET', 'orgStudyIdInfo': {'id': 'BWH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Regadenoson (Lexiscan)', 'description': 'Regadenoson Rubidium-82 Positron Emission Tomography', 'interventionNames': ['Drug: Regadenoson (Lexiscan)']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise + Regadenoson (Lexercise)', 'description': 'Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography', 'interventionNames': ['Drug: Exercise plus Regadenoson (Lexercise)']}], 'interventions': [{'name': 'Exercise plus Regadenoson (Lexercise)', 'type': 'DRUG', 'otherNames': ['Exercise plus Lexiscan'], 'description': 'Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography', 'armGroupLabels': ['Exercise + Regadenoson (Lexercise)']}, {'name': 'Regadenoson (Lexiscan)', 'type': 'DRUG', 'description': 'Regadenoson Rubidium-82 Positron Emission Tomography', 'armGroupLabels': ['Regadenoson (Lexiscan)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02421', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Womens' Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sharmila Dorbala, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Nuclear Cardiology', 'investigatorFullName': 'Sharmila Dorbala, MBBS', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}