Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT01155167
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2010-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Topical Radial Artery Vasodilation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013035', 'term': 'Spasm'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aboyle@medicne.ucsf.edu', 'phone': '4153533817', 'title': 'Andrew Boyle MD', 'organization': 'UCSF'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Topical Dilator', 'description': '40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Radial Artery Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.'}, {'id': 'OG001', 'title': 'Topical Dilator', 'description': '40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 30 minutes of drug application', 'description': 'The cross-sectional radial artery area was measured using a high frequency linear array transducer. All ultrasound measurements were made 2 cm proximal to the radial styloid process. Each measurement was performed 3 times and averaged. At least 30 minutes after the application of topical creams, the radial artery diameter was again measured in the same fashion.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Radial Artery Spasm During Catheterization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.'}, {'id': 'OG001', 'title': 'Topical Dilator', 'description': '40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.'}], 'classes': [{'title': 'Spasm', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'No spasm', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'The blinded clinical operator recorded whether radial artery spasm occurred, as detected by resistance to advancing the catheter through the radial artery, by difficulty in torquing the catheter, or by difficulty in removing the catheter.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except 3 participants in the Topical Dilator arm for whom RAS data were not recorded'}, {'type': 'SECONDARY', 'title': 'Radial Artery Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.'}, {'id': 'OG001', 'title': 'Topical Dilator', 'description': '40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.'}], 'classes': [{'title': 'Patent radial artery', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Early radial artery occlusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Prior to discharge, color doppler ultrasound was used at the site where the sheath had been inserted to determine whether the radial artery was patent (open, unobstructed).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Two placebo topical lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.'}, {'id': 'FG001', 'title': 'Topical Dilator', 'description': '40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Insufficient ultrasound data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Access site changed to femoral artery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Eligible patients scheduled to undergo clinically indicated diagnostic or therapeutic cardiac catheterization via the transradial approach were invited to participate in the study', 'preAssignmentDetails': "3 participants from the placebo group were excluded (2 secondary to insufficient or uninterpretable ultrasound data and 1 secondary to patient's access site change from transradial access (TRA) to femoral access)."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.'}, {'id': 'BG001', 'title': 'Topical Dilator', 'description': '40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2010-06-29', 'resultsFirstSubmitDate': '2013-01-31', 'studyFirstSubmitQcDate': '2010-06-30', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-13', 'studyFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Radial Artery Diameter', 'timeFrame': 'Baseline and after 30 minutes of drug application', 'description': 'The cross-sectional radial artery area was measured using a high frequency linear array transducer. All ultrasound measurements were made 2 cm proximal to the radial styloid process. Each measurement was performed 3 times and averaged. At least 30 minutes after the application of topical creams, the radial artery diameter was again measured in the same fashion.'}], 'secondaryOutcomes': [{'measure': 'Radial Artery Spasm During Catheterization', 'timeFrame': '2 hours', 'description': 'The blinded clinical operator recorded whether radial artery spasm occurred, as detected by resistance to advancing the catheter through the radial artery, by difficulty in torquing the catheter, or by difficulty in removing the catheter.'}, {'measure': 'Radial Artery Patency', 'timeFrame': '24 hours', 'description': 'Prior to discharge, color doppler ultrasound was used at the site where the sheath had been inserted to determine whether the radial artery was patent (open, unobstructed).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radial artery spasm'], 'conditions': ['Cardiac Catheterization', 'Spasm']}, 'referencesModule': {'references': [{'pmid': '23582415', 'type': 'DERIVED', 'citation': 'Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, Ports TA, Boyle AJ. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol. 2013 Oct 3;168(3):2575-8. doi: 10.1016/j.ijcard.2013.03.048. Epub 2013 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to facilitate radial artery access for cardiac catheterization. The investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized to topical nitroglycerin + lidocaine versus placebo.', 'detailedDescription': 'The aim of the study is to facilitate radial artery access for cardiac catheterization. The investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized to topical nitroglycerin + lidocaine versus placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing trans-radial cardiac catheterization\n\nExclusion Criteria:\n\n* inability to receive nitroglycerin or lidocaine due to allergy or medication interactions'}, 'identificationModule': {'nctId': 'NCT01155167', 'briefTitle': 'Topical Radial Artery Vasodilation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Effect of Topical Administration of Lidocaine/Nitroglycerin Combination Versus Placebo on Radial Artery Access in Patients Undergoing Cardiac Catheterization Via the Radial Artery', 'orgStudyIdInfo': {'id': '10035824'}, 'secondaryIdInfos': [{'id': 'CHR # 10035824', 'type': 'OTHER', 'domain': 'UCSF'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Topical dilator', 'interventionNames': ['Drug: Nitroglycerin and lidocaine']}], 'interventions': [{'name': 'Nitroglycerin and lidocaine', 'type': 'DRUG', 'description': 'Topical Nitroglycerin and lidocaine', 'armGroupLabels': ['Topical dilator']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Andrew Boyle, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}