Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-27 @ 7:53 AM
Study NCT ID:
NCT04869150
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2021-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054084', 'term': 'Myocardial Bridging'}], 'ancestors': [{'id': 'D003330', 'term': 'Coronary Vessel Anomalies'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography?', 'timeFrame': '1 month', 'description': 'the incidence of MB able to be detected on RACA was much higher than reported in previous CCA studies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myocardial bridge', 'radial access coronary angiography'], 'conditions': ['Myocardial Bridge of Coronary Artery']}, 'descriptionModule': {'briefSummary': 'Although the incidence of myocardial bridge (MB) has been defined in different conventional coronary angiography (CCA) studies,the frequency of MB in radial access coronary angiography (RACA) is unknown.The aim of this study was to determine the incidence of MB in patients undergoing RACA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective evaluation was made of the coronary angiographies of 2600 consecutive patients who underwent radial access coronary angiography between January 2018 and February 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing radial access coronary angiography\n* Have myocardial bridge\n\nExclusion Criteria:\n\n* A history of coronary artery bypass grafting (CABG)'}, 'identificationModule': {'nctId': 'NCT04869150', 'briefTitle': 'Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Bakircay University'}, 'officialTitle': 'Cigli Training and Research Hospital Organization', 'orgStudyIdInfo': {'id': '223-205'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'those with myocardial bridges', 'interventionNames': ['Procedure: radial access coronary angiography']}, {'label': 'those without myocardial bridges'}], 'interventions': [{'name': 'radial access coronary angiography', 'type': 'PROCEDURE', 'description': "The right radial artery was cannulated with a 6-f radial sheath after local infiltration with 2% lidocaine.All patients received 5000 units of unfractionated heparin, 100 - 200 μg (depending on blood pressure) of nitroglycerin and 5 mg of diltiazem unless there was an absolute contraindication to diltiazem and anticoagulants.Coronary angiography was performed using the standard Judkins' technique via right radial access with a 5-f diagnostic catheter", 'armGroupLabels': ['those with myocardial bridges']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Cigli Training and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Bakircay University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Oktay Senoz', 'investigatorAffiliation': 'Izmir Bakircay University'}}}}