Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-04 @ 6:00 PM
Study NCT ID:
NCT00837369
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2009-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Regadenoson R-T Perfusion Imaging Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C430916', 'term': 'regadenoson'}, {'id': 'C042852', 'term': 'perflutren'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trporter@unmc.edu', 'phone': '402-559-5151', 'title': 'Thomas Porter', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 hour observation', 'description': 'Non-serious adverse persisted no more than 5 minutes for chest pain, shortness of breath \\& back pain. Headaches were reported within 1 hour.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm One', 'description': 'RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement.\n\nRegadenoson: 400ug IV bolus injection, single dosage\n\nNon-serious adverse effects during Regadenoson and Definity administration included chest pain in 7% of patients, shortness of breath in 48%, headache in 23% and back pain in 4%.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 82, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chest Pain', 'notes': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of Breath', 'notes': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 48, 'numAffected': 48}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'notes': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Wall Motion', 'description': 'RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion.\n\nWall motion was assessed by scoring as follows: 1=normal, 2=hypokinetic, 3=akinetic, and 4=dyskinetic.\n\nAn inducible wall motion abnormality was one in which a new wall motion abnormality was evident after regadenoson bolus within at least 2 contiguous segments. A fixed defect was one in which the abnormality,was present at rest and did not change after the regadenoson bolus.'}, {'id': 'OG001', 'title': 'Myocardial Perfusion', 'description': 'RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine myocardial perfusion.\n\nMyocardial perfusion was assessed by examination of myocardial contrast replenishment after brief high mechanical index impulses. A perfusion defect was defined as a delay (\\>2 seconds) in myocardial contrast replenishment in 2 contiguous segments.'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'Compare the differences in sensitivity between myocardial perfusion and wall motion for detecting stenosis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Compare the sensitivity of myocardial perfusion in detecting stenosis within the first 4 minutes after regadenoson bolus injection to that of wall motion', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour observation post perfusion', 'description': 'Regadenoson real-time myocardial contrast echocardiography can be used to detect coronary artery stenosis during Regadenoson stress.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '60 Males, 40 Females being evaluated for coronary artery disease.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Regadenoson 400 ug IV Bolus Injection', 'description': 'Real time perfusion (RTPE) studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement.\n\nRegadenoson: 400ug IV bolus injection, single dosage'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Regadenoson', 'description': 'RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement.\n\nRegadenoson: 400ug IV bolus injection, single dosage'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2011-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2009-02-03', 'resultsFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2009-02-03', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-16', 'studyFirstPostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress', 'timeFrame': '1 hour observation post perfusion', 'description': 'Regadenoson real-time myocardial contrast echocardiography can be used to detect coronary artery stenosis during Regadenoson stress.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress echocardiography', 'SPECT', 'Myocardial perfusion imaging'], 'conditions': ['Coronary Artery Disease', 'Myocardial Perfusion Abnormalities']}, 'descriptionModule': {'briefSummary': 'To exam the feasibility and accuracy of Regadenoson real time perfusion (RTPE) Imaging during vasodilator stress with Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography.', 'detailedDescription': 'To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the adenosine receptor (A2A) agonist Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and accuracy of perfusion and wall motion analysis to identify a coronary stenosis\\> 50% in diameter by quantitive angiography will be analyzed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female. Age ≥30 years.\n* Resting Left Ventricular Ejection Fraction \\> 40% using Simpson's biplane measurement.\n* Scheduled for coronary angiography within 30 days of the Regadenoson stress test.\n* Negative urine pregnancy test within 2 hours of ultrasound contrast administration required of females of childbearing age unless post-menopausal or with evidence of surgical sterilization.\n* Be conscious and coherent, and able to communicate effectively with trial personnel.\n* Agreeable to undergo the additional stress test and coronary angiography\n* Have at least an intermediate likelihood of coronary disease based on the following clinical profile\n* Good apical echo images with at least 50% of each coronary artery territory well visualized.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to ultrasound contrast agent used for the study.\n* Pregnancy or lactation.\n* Complicated hemodynamic instability (i.e., New York Heart Association (NYHA) Class IV heart failure, unstable angina at rest despite medical therapy).\n* Life expectancy of less than two months or terminally ill.\n* Congestive (idiopathic) or hypertrophic cardiomyopathy.\n* Known left main disease.\n* Heart transplant recipient, hypertrophic cardiomyopathy, acute myo- or pericarditis.\n* Resting Left Ventricular Ejection Fraction \\< 40%\n* Large inducible perfusion defects or wall motion abnormalities during prior stress imaging study associated with left ventricular cavity dilatation.\n* Early positive treadmill EKG within the first stage of the test.\n* History of \\>1st degree heart block, sick sinus syndrome or high grade atrioventricular (AV) block without a pacemaker.\n* Dipyridamole use within 30 hours of stress test, or consumption of methylxanthines within 12 hours, or use of sublingual nitroglycerin within two hours.\n* Participation In another investigational study within one month of this study."}, 'identificationModule': {'nctId': 'NCT00837369', 'briefTitle': 'Regadenoson R-T Perfusion Imaging Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Regadenoson Real Time Perfusion Imaging Trial', 'orgStudyIdInfo': {'id': '0566-08-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Real time perfusion (RTPE) imaging following Regadenoson', 'description': 'RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement.', 'interventionNames': ['Drug: Regadenoson']}], 'interventions': [{'name': 'Regadenoson', 'type': 'DRUG', 'otherNames': ['Definity (Lantheus Medical Imaging)', 'Lipid encapsulated microbubbles'], 'description': '400ug IV bolus injection, single dosage', 'armGroupLabels': ['1 Real time perfusion (RTPE) imaging following Regadenoson']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medicial Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Thomas R Porter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}