Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT01482169
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2011-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rbober@ochsner.org', 'phone': '504-842-4135', 'title': 'Dr. Robert Bober', 'organization': 'Ochsner Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Subjects were monitored during and post-procedure until discharge from the procedure. This duration was less than 24 hours for each participant.', 'description': 'Definitions do not differ.', 'eventGroups': [{'id': 'EG000', 'title': 'Adenoscan', 'description': 'Subjects will have the FFR Measurement with IV Adenoscan®\n\nFFR Measurement with IV Adenoscan®: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®.', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Regadenson', 'description': 'Subjects will have the FFR Measurement with IV Regadenson\n\nFFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved.', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparing Measurement of Fractional Flow Reserve (FFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adenoscan', 'description': 'Subjects will have the FFR Measurement with IV Adenoscan®\n\nFFR Measurement with IV Adenoscan®: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®.'}, {'id': 'OG001', 'title': 'Regadenoson', 'description': 'Subjects will have the FFR Measurement with IV Regadenson\n\nFFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '.83', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '.84', 'spread': '0.084', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'DAY 1', 'description': 'For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded.', 'unitOfMeasure': 'FFR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration to Baseline Hyperemia After Aminophylline Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duration to Baseline Hyperemia After Aminophylline Administrat', 'description': 'After subjects have the FFR measurement with Regadenoson, they will be administered aminophylline 150mg IV and the time duration to reach baseline hyperemia will be recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'spread': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'seconds', 'description': 'In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 48 patients enrolled, 7 of the patients did not have measurements for the secondary outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adenoscan + Regadenoson', 'description': 'Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson\n\nFFR Measurement with IV Adenoscan® then with Regadenoson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adenoscan + Regadenoson', 'description': 'Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson\n\nFFR Measurement with IV Adenoscan® then with Regadenoson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2011-11-15', 'resultsFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-09', 'studyFirstPostDateStruct': {'date': '2011-11-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing Measurement of Fractional Flow Reserve (FFR)', 'timeFrame': 'DAY 1', 'description': 'For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Duration to Baseline Hyperemia After Aminophylline Injection', 'timeFrame': 'seconds', 'description': 'In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Left heart catheterization', 'Fractional flow reserve', 'Adenoscan®', 'Regadenoson'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.', 'detailedDescription': 'This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will be enrolled and get Adenoscan® administered via IV followed by Regadenoson IV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective left heart catheterization\n* Age ≥ 18 years (female not of child bearing potential)\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Contraindications to administration of either Adenoscan® or Regadenoson\n* High degree AV block, sick sinus syndrome without a functioning pacemaker\n* Symptomatic bradycardia\n* Recent STEMI (\\< 5 days)\n* Recent NSTEMI (\\<5 days) if the peak CK is \\> 1000 IU\n* Dipyridamole use within 24 hours\n* Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or aminophylline\n* Known severe bronchoconstrictive lung disease'}, 'identificationModule': {'nctId': 'NCT01482169', 'briefTitle': 'Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements', 'orgStudyIdInfo': {'id': '10012012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adenoscan', 'description': 'Subjects will have the FFR Measurement with IV Adenoscan®', 'interventionNames': ['Drug: FFR Measurement with IV Adenoscan® then with Regadenoson']}, {'type': 'EXPERIMENTAL', 'label': 'Regadenoson', 'description': 'Subjects will have the FFR Measurement with IV Regadenoson', 'interventionNames': ['Drug: FFR Measurement with IV Adenoscan® then with Regadenoson']}], 'interventions': [{'name': 'FFR Measurement with IV Adenoscan® then with Regadenoson', 'type': 'DRUG', 'otherNames': ['Adenoscan® vs Regadenoson'], 'description': 'Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny.', 'armGroupLabels': ['Adenoscan', 'Regadenoson']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Robert Bober, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ochsner Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ochsner Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Astellas Pharma Global Development, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Nuclear Cardiology', 'investigatorFullName': 'Robert Bober, M.D.', 'investigatorAffiliation': 'Ochsner Health System'}}}}