{
  "FullStudy":{
    "Rank":218281,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510353",
          "OrgStudyIdInfo":{
            "OrgStudyId":"11-097"
          },
          "Organization":{
            "OrgFullName":"North Texas Veterans Healthcare System",
            "OrgClass":"FED"
          },
          "BriefTitle":"Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization",
          "OfficialTitle":"Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 2, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 4, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Emmanouil Brilakis",
            "ResponsiblePartyInvestigatorTitle":"Director, Cardiac Catheterization Laboratories",
            "ResponsiblePartyInvestigatorAffiliation":"North Texas Veterans Healthcare System"
          },
          "LeadSponsor":{
            "LeadSponsorName":"North Texas Veterans Healthcare System",
            "LeadSponsorClass":"FED"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to examine the impact of using a real time radiation exposure monitoring device on the patient and operator radiation exposure during cardiac catheterization. The hypothesis of the study is that use of a real time radiation exposure monitoring device during cardiac catheterization will decrease both patient and operator radiation exposure compared to no use of the monitoring device."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Radiation Monitoring",
              "Radiation Protection"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"505",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Use of a radiation monitoring device",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Radiation monitoring device"
                  ]
                }
              },{
                "ArmGroupLabel":"No use of radiation monitoring device",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"No use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Radiation monitoring device",
                "InterventionDescription":"Radiation monitoring device (Bleeper Sv, Vertec Scientific Ltd, Berkshire, UK) that provides real-time auditory feedback on radiation exposure during cardiac catheterization",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Use of a radiation monitoring device"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Radiation exposure of the operator",
                "PrimaryOutcomeDescription":"Radiation exposure of the operator (measured in mrem by the real time monitoring device)",
                "PrimaryOutcomeTimeFrame":"radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Radiation exposure of the patient",
                "SecondaryOutcomeDescription":"Radiation exposure of the patient, as measured by the X-ray machine using (a) air kerma dose, (b) dose area product, (c) fluoroscopy and cineangiography time",
                "SecondaryOutcomeTimeFrame":"radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients undergoing clinically-indicated cardiac catheterization\n\nExclusion Criteria:\n\nNone",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Emmanouil S. Brilakis, MD, PhD",
                "OverallOfficialAffiliation":"North Texas Veterans Healthcare System",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Subhash Banerjee, MD",
                "OverallOfficialAffiliation":"North Texas Veterans Healthcare System",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"VA North Texas Health Care System",
                "LocationCity":"Dallas",
                "LocationState":"Texas",
                "LocationZip":"75216",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"25423958",
                "ReferenceType":"derived",
                "ReferenceCitation":"Christopoulos G, Papayannis AC, Alomar M, Kotsia A, Michael TT, Rangan BV, Roesle M, Shorrock D, Makke L, Layne R, Grabarkewitz R, Haagen D, Maragkoudakis S, Mohammad A, Sarode K, Cipher DJ, Chambers CE, Banerjee S, Brilakis ES. Effect of a real-time radiation monitoring device on operator radiation exposure during cardiac catheterization: the radiation reduction during cardiac catheterization using real-time monitoring study. Circ Cardiovasc Interv. 2014 Dec;7(6):744-50. doi: 10.1161/CIRCINTERVENTIONS.114.001974. Epub 2014 Nov 25."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}