Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT03576456
Status:
UNKNOWN
Last Update Posted:
2018-10-12
First Post:
2018-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sedative Premedication in Coronary Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000525', 'term': 'Alprazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'placebo controlled, double blind'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-11', 'studyFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2018-07-02', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preprocedural anxiety: visual analogue scale', 'timeFrame': 'Assessed before the coronary angiography', 'description': 'anxiety prior to coronary angiography. Assessed before the procedure through a visual analogue scale for anxiety (VAS-A). The VAS is a visual scale ranging from 0 to 100 with 0 begin no anxiety at all and 100 begin extreme anxiety.'}, {'measure': 'periprocedural pain: visual analogue scale', 'timeFrame': 'Assessed after the coronary angiography, within 4 hours.', 'description': 'pain during to coronary angiography. Assessed after the procedure through a visual analogue scale for pain. The VAS scale is a visual scale ranging from 0 (no pain) to 100 (extreme pain).'}], 'secondaryOutcomes': [{'measure': 'radial spasm', 'timeFrame': 'during procedure', 'description': 'spasm of the radial artery as experienced by operator. There is no precise measurement up until today.'}, {'measure': 'vascular site access complication', 'timeFrame': 'during procedure', 'description': 'need to switch to femoral access, assessed by the operator.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary angiography', 'premedication', 'pain', 'anxiety'], 'conditions': ['Coronary Angiography', 'Sedative Premedication']}, 'descriptionModule': {'briefSummary': 'Evaluation of the possible positive effect of sedative premedication prior to coronary angiography in regards to pain and anxiety.', 'detailedDescription': 'Coronary angiography is an invasive procedure that can cause patient discomfort. Sedative premedication before coronary angiography could be used to reduce anxiety and pain, but evidence is lacking. Previous trials were predominantly conducted in men and in coronary interventions with femoral access. Recently, radial access has become the preferred route for performing coronary angiograms (RIVAL trial) In this setting, sedative premedication could be of interest to reduce radial spasms, patient anxiety and pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective coronary angiography\n\nExclusion Criteria:\n\n* planned PCI\n* use of sedative medication at home\n* use of alcohol'}, 'identificationModule': {'nctId': 'NCT03576456', 'briefTitle': 'Sedative Premedication in Coronary Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Sedative Premedication in Coronary Angiography', 'orgStudyIdInfo': {'id': 'awxg2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alprazolam', 'description': 'Patients receive alprazolam 0.5 mg 1 hour prior to coronary angiography.', 'interventionNames': ['Drug: Alprazolam 0.5 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Tablet', 'description': 'Patients receive placebo 1 hour prior to coronary angiography.', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Alprazolam 0.5 mg', 'type': 'DRUG', 'description': 'receive alprazolam prior to angio', 'armGroupLabels': ['Alprazolam']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'receive placebo prior to angio', 'armGroupLabels': ['Placebo Oral Tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'state': 'Jette', 'country': 'Belgium', 'contacts': [{'name': 'Adriaan Wilgenhof, MD', 'role': 'CONTACT', 'email': 'adriaan.wilgenhof@gmail.com', 'phone': '003224776009'}, {'name': 'Xavier Galloo, MD', 'role': 'CONTACT', 'phone': '003224776009'}], 'facility': 'Adriaan Wilgenhof', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Adriaan Wilgenhof, MD', 'role': 'CONTACT', 'email': 'adriaan.wilgenhof@gmail.com', 'phone': '003224776009'}], 'overallOfficials': [{'name': 'Danny Schoors, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of service'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'within 1 month, during 1 year', 'ipdSharing': 'YES', 'accessCriteria': 'researcher'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Principal Investigator', 'investigatorFullName': 'Wilgenhof Adriaan', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}