Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-21 @ 11:20 PM
Study NCT ID:
NCT02128035
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RADIATION PROTECTion With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2014-04-29', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Radiation Dose', 'timeFrame': 'Duration of Procedure (an expected average of 30 minutes)', 'description': '1. The total radiation dose that the interventional cardiologist got exposed to as read by dosimeters (µSv) at left breast.\n2. The difference between both groups in radiation dose that the interventional cardiologist got exposed to divided by Air Kerma (µSv/mGy).\n3. For the radiation protection cap, the primary outcome is the difference between total radiation dose as measured by two dosimeters (µSv) at left temporal region of the head of the interventional cardiologist (one on the outside of the radiation protection cap and the other one on the inside of the cap).'}], 'secondaryOutcomes': [{'measure': 'Radiation Exposure Dose per minute', 'timeFrame': 'Duration of Procedure (an expected average of 30 minutes)', 'description': 'The difference between both groups in radiation exposure dose per minute (µSv /min) at left breast and left temporal region.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radiation protection', 'interventional cardiologist', 'percutaneous coronary intervention (PCI)', 'angiography', 'lead shield'], 'conditions': ['Acute Coronary Syndromes']}, 'referencesModule': {'references': [{'pmid': '26253734', 'type': 'DERIVED', 'citation': 'Alazzoni A, Gordon CL, Syed J, Natarajan MK, Rokoss M, Schwalm JD, Mehta SR, Sheth T, Valettas N, Velianou J, Pandie S, Al Khdair D, Tsang M, Meeks B, Colbran K, Waller E, Fu Lee S, Marsden T, Jolly SS. Randomized Controlled Trial of Radiation Protection With a Patient Lead Shield and a Novel, Nonlead Surgical Cap for Operators Performing Coronary Angiography or Intervention. Circ Cardiovasc Interv. 2015 Aug;8(8):e002384. doi: 10.1161/CIRCINTERVENTIONS.115.002384.'}]}, 'descriptionModule': {'briefSummary': 'RADIATION PROTECT is a randomized, controlled trial of patients undergoing coronary angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.\n\nIt is hypothesized that routine use of the pelvic lead shield and radiation protection cap during these procedures will reduce the amount of radiation in which the interventional cardiologists get exposed.', 'detailedDescription': 'Patients referred for coronary angiography or PCI will be randomized to undergo their procedure with or without the pelvic lead shield and the operator will wear a radiation protection cap.\n\nClinical efficacy will be assessed based on the total radiation dose that the interventional cardiologist got exposed to as well as a secondary outcome measuring the total radiation exposure dose per minute.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient referred for coronary angiography or Percutaneous Coronary Intervention (PCI)\n\nExclusion Criteria:\n\n* Age ≤ 18 years\n* Previous inclusion in RADIATION PROTECT trial'}, 'identificationModule': {'nctId': 'NCT02128035', 'briefTitle': 'RADIATION PROTECTion With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Radiation Protection With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RADIATION PROTECT'}, 'secondaryIdInfos': [{'id': 'Project Number 12-520', 'type': 'OTHER', 'domain': 'Hamilton Health Sciences Research Ethics Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Without Lead Shield', 'description': "All routine measures to reduce radiation exposure (including lead aprons, lead collar, lead lenses, movable ceiling suspended lead shield with a long lead skirt attached to its lower margin) will be used as done routinely and will be left to the operators' discretion.\n\nThe LEAD SHIELD will not be used in this group.\n\nInterventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures."}, {'type': 'EXPERIMENTAL', 'label': 'With Lead Shield', 'description': "All routine measures to reduce radiation exposure (including lead aprons, lead collar, lead lenses, movable ceiling suspended lead shield with a long lead skirt attached to its lower margin) will be used as done routinely and will be left to the operators' discretion.\n\nIn this group, a LEAD SHIELD will be used. The Pelvic lead shield will be draped on patient from umbilicus to knees.\n\nInterventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.", 'interventionNames': ['Procedure: With Lead Shield']}], 'interventions': [{'name': 'With Lead Shield', 'type': 'PROCEDURE', 'description': 'A pelvic lead shield will be draped on patient from umbilicus to knees.\n\nInterventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.', 'armGroupLabels': ['With Lead Shield']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Sanjit S Jolly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Health Sciences, McMaster University'}, {'name': 'Ashraf Al Azzoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Health Sciences Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Sanjit S. Jolly', 'class': 'OTHER'}, 'collaborators': [{'name': 'McMaster University', 'class': 'OTHER'}, {'name': 'Population Health Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Interventional Cardiologist, Associate Professor', 'investigatorFullName': 'Dr. Sanjit S. Jolly', 'investigatorAffiliation': 'Population Health Research Institute'}}}}