Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-09 @ 5:46 AM
Study NCT ID:
NCT05317533
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2022-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Distal Radial Artery Occlusion in Cardiovascular Catheterization Via Distal Radial Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 805}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of distal radial artery occlusion', 'timeFrame': '3 months after procedure', 'description': 'Prevalence of the distal radial artery occlusion is detected using ultrasound'}], 'secondaryOutcomes': [{'measure': 'Prevalence of distal radial artery occlusion', 'timeFrame': '1 day after procedure', 'description': 'Prevalence of the distal radial artery occlusion is detected using ultrasound'}, {'measure': 'Thickness of distal radial artery', 'timeFrame': '3 months after procedure', 'description': 'Comparison of the thickness of distal radial artery intima using ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['distal radial artery occlusion;cardiac catheterization'], 'conditions': ['Catheterization', 'Complications', 'Distal Radial Artery']}, 'referencesModule': {'references': [{'pmid': '33380922', 'type': 'RESULT', 'citation': 'Lin Y, Sun X, Chen R, Liu H, Pang X, Chen J, Dong S. Feasibility and Safety of the Distal Transradial Artery for Coronary Diagnostic or Interventional Catheterization. J Interv Cardiol. 2020 Dec 9;2020:4794838. doi: 10.1155/2020/4794838. eCollection 2020.'}, {'pmid': '30336816', 'type': 'RESULT', 'citation': 'Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j.jcin.2018.04.045.'}, {'pmid': '35248389', 'type': 'RESULT', 'citation': 'Sattar Y, Talib U, Faisaluddin M, Song D, Lak HM, Laghari A, Khan MZ, Ullah W, Elgendy IY, Balla S, Daggubati R, Kawsara A, Jneid H, Alraies CM, Alam M. Meta-Analysis Comparing Distal Radial Versus Traditional Radial Percutaneous Coronary Intervention or Angiography. Am J Cardiol. 2022 May 1;170:31-39. doi: 10.1016/j.amjcard.2022.01.019. Epub 2022 Mar 2.'}, {'pmid': '34815063', 'type': 'RESULT', 'citation': 'Prasad RM, Pandrangi P, Pandrangi G, Yoo H, Salazar AM, Ukponmwan E, Kehdi M, Abela G. Meta-Analysis Comparing Distal Radial Artery Approach Versus Traditional for Coronary Procedures. Am J Cardiol. 2022 Feb 1;164:52-56. doi: 10.1016/j.amjcard.2021.10.034. Epub 2021 Nov 20.'}, {'pmid': '34783423', 'type': 'RESULT', 'citation': 'Pacchioni A, Mugnolo A, Sanz Sanchez J, Sgueglia GA, Pesarini G, Bellamoli M, Sacca S, Ribichini F, Reimers B, Gasparini GL. Radial artery occlusion after conventional and distal radial access: Impact of preserved flow and time-to-hemostasis in a propensity-score matching analysis of 1163 patients. Catheter Cardiovasc Interv. 2022 Feb;99(3):827-835. doi: 10.1002/ccd.30005. Epub 2021 Nov 16.'}, {'pmid': '34666014', 'type': 'RESULT', 'citation': 'Aminian A, Sgueglia GA, Wiemer M, Gasparini GL, Kefer J, Ruzsa Z, van Leeuwen MAH, Vandeloo B, Ungureanu C, Kedev S, Iglesias JF, Leibundgut G, Ratib K, Bernat I, Barriocanal I, Borovicanin V, Saito S. Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study. Am Heart J. 2022 Feb;244:19-30. doi: 10.1016/j.ahj.2021.10.180. Epub 2021 Oct 16.'}, {'pmid': '35236288', 'type': 'RESULT', 'citation': 'Li F, Shi GW, Yu XL, Song RX, Xiao JQ, Huang HM, Li LM, Zhang LY, Gong C, Cai GJ. Safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial artery access in the anatomical snuffbox: a single-centre prospective cohort study using a propensity score method. BMC Cardiovasc Disord. 2022 Mar 2;22(1):74. doi: 10.1186/s12872-022-02518-8.'}, {'pmid': '35001676', 'type': 'RESULT', 'citation': 'Shi G, Li F, Zhang L, Gong C, Xue S, Song Y, Cai G. Retrograde Recanalization of Occluded Radial Artery: A Single-Centre Experience and Literature Review. J Endovasc Ther. 2022 Oct;29(5):755-762. doi: 10.1177/15266028211067732. Epub 2022 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'Explore the prevalence of distal radial artery occlusion after cardiac catheterization via distal radial artery and the risk factors', 'detailedDescription': 'Cardiac catheterization via distal radial artery is prevalent worldwide, which can reduce the prevalence of radial artery occlusion. However, the distal radial artery occlusion has not been detected. This study is designed to explore the prevalence of distal radial artery occlusion in patients undergoing cardiac catheterization via distal radial access at 1 day and 3 months after the procedure, which is explored by ultrasound. In addition, the risk factors of distal radial artery occlusion are also analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects consist of patients who present to the cardiac catheterization laboratory for an angiogram or percutaneous intervention for the first time.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Palpable distal radial artery\n\nExclusion Criteria:\n\n* Age ≥ 90years;\n* Height≥ 185cm;\n* Cardiogenic shock;\n* Refuse to sign the written informed consent.'}, 'identificationModule': {'nctId': 'NCT05317533', 'briefTitle': 'Prevalence of Distal Radial Artery Occlusion in Cardiovascular Catheterization Via Distal Radial Access', 'organization': {'class': 'OTHER', 'fullName': "Wujin People's Hospital"}, 'officialTitle': 'Prevalence of Distal Radial Artery Occlusion (DRAO) in Patients Undergoing Cardiovascular Catheterization Via Distal Radial Access (DRA)', 'orgStudyIdInfo': {'id': 'CLH20220312'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cardiac catheterization via distal radial artery', 'type': 'PROCEDURE', 'description': 'cardiac catheterization via distal radial artery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '213017', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Changzhou Wujin People's Hospital", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}], 'overallOfficials': [{'name': 'Gaojun Cai, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Cardiovascular department, Changzhou Wujin People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Wujin People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}