Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-02 @ 4:17 AM
Study NCT ID:
NCT05625503
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2022-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dilution of Verapamil During Intraarterial Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010292', 'term': 'Paresthesia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'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': 'D014700', 'term': 'Verapamil'}, {'id': 'D002121', 'term': 'Calcium Channel Blockers'}, {'id': 'D009529', 'term': 'Nicardipine'}], 'ancestors': [{'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000077264', 'term': 'Calcium-Regulating Hormones and Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2022-11-11', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radial Artery Spasm', 'timeFrame': 'approximately 30 minutes', 'description': 'The investigators will document the presence or absence of radial artery spasms with either 0,1, or 2. 0 will indicate no radial artery spasms. 1 will indicate radial artery spasms that did not require a change in strategy. 2 will indicate radial artery spasms that required a change in strategy such as alternate access.'}, {'measure': 'Pain Prior to Intra-arterial Calcium Channel Blocker Administration', 'timeFrame': '30 seconds prior to administration', 'description': 'Pain prior to intra-arterial calcium channel blocker administration will be assessed through the Visual Analogue Pain scale (from 0 to 10).'}, {'measure': 'Pain After Intra-arterial Calcium Channel Blocker Administration', 'timeFrame': '30 seconds post administration', 'description': 'Pain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac catheterization', 'intra-arterial calcium channel blockers', 'radial artery spasm'], 'conditions': ['Vasospasm;Peripheral', 'Burning', 'Pain']}, 'descriptionModule': {'briefSummary': "This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via TRA will be included. Patients who are non-English speaking, pregnant, or intubated will be excluded. Patients will be randomized to one of the two following groups:\n\n1. Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline\n2. Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL)\n\nThe investigators will document the patient's level of discomfort on the Visual Analogue Scale 30 seconds before and after administration of IA Verapamil/Nicardipine. The investigators will also document the presence of radial artery spasms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* English Speaking patients who are age 18 or older\n* Patient must be able to provide own consent and communicate with staff\n* Patient's undergoing transradial access (TRA) for the left heart catheterization (LHC)\n\nExclusion Criteria\n\n* Intubated or sedated patients\n* Agitated patients requiring moderate sedation prior to TRA\n* Patient's undergoing femoral access for the LHC\n* Non-English speaking patients\n* Contraindications to Verapamil or Nicardipine: including allergies to these medications, hypotension (mean arterial pressure \\<65), Bradycardia (heart rate\\<40)\n* Emergent cardiac catheterization\n* Inability to obtain radial artery access\n* Conversion to radial artery access from another access site"}, 'identificationModule': {'nctId': 'NCT05625503', 'briefTitle': 'Dilution of Verapamil During Intraarterial Administration', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Does Dilution of Verapamil With Normal Saline or Blood Reduce Discomfort Felt During Intraarterial Administration?', 'orgStudyIdInfo': {'id': '2022-0722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Verapamil', 'description': 'Intra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline', 'interventionNames': ['Drug: Verapamil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nicardipine', 'description': 'Intra-arterial Nicardipine 400 mcg undiluted (8mL)', 'interventionNames': ['Drug: Nicardipine']}], 'interventions': [{'name': 'Verapamil', 'type': 'DRUG', 'otherNames': ['Calcium channel blocker'], 'description': 'All patients routinely receive intra-arterial calcium channel blockers during transradial access for coronary angiography.', 'armGroupLabels': ['Verapamil']}, {'name': 'Nicardipine', 'type': 'DRUG', 'description': 'Calcium channel blocker', 'armGroupLabels': ['Nicardipine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Khalil Ibrahim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Medicine', 'investigatorFullName': 'Khalil Ibrahim', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}