{
  "FullStudy":{
    "Rank":217547,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519973",
          "OrgStudyIdInfo":{
            "OrgStudyId":"HI Protocol #2008012-01H"
          },
          "Organization":{
            "OrgFullName":"Ottawa Heart Institute Research Corporation",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Optimization of SPECT Imaging",
          "OfficialTitle":"Optimization of SPECT Cardiac Imaging Through Compensation for Attenuation, Resolution Loss and Scatter - The OSCARS",
          "Acronym":"OSCARS"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2017",
          "OverallStatus":"Terminated",
          "WhyStopped":"Recruitment base changed due to change in clinical acquisition procedures",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2008"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"July 15, 2011",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 27, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 21, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 24, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Terrence Ruddy",
            "ResponsiblePartyInvestigatorTitle":"Terrence Ruddy, MD",
            "ResponsiblePartyInvestigatorAffiliation":"Ottawa Heart Institute Research Corporation"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Ottawa Heart Institute Research Corporation",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Single Photon Emission Computed Tomography (SPECT) is a 3D nuclear medicine imaging technique that is used extensively to study the heart and diagnose heart disease. There are three major limitations in SPECT imaging: attenuation or loss of signal, scattering of the signal in the patient tissues and resolution, where the signal gets blurrier the further the nuclear activity is away from the camera. New software, Evolution for CardiacTM, by GE Healthcare and new cameras with computed tomography (CT) decrease the time needed for images to be obtained while maintaining image quality. Evaluation is needed before they become standard of care."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Coronary Artery Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Diagnostic imaging",
              "Single Photon Emission Computed Tomography",
              "Positron emission tomography",
              "Computed tomography",
              "Attenuation",
              "Resolution",
              "Scatter",
              "Radiopharmaceutical"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Other",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"64",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Evaluation of technology in SPECT",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Evaluation of the accuracy of SPECT with new technologies for attenuation correction (AC), scatter correction (SC) and resolution recovery (RR) for assessment of myocardial perfusion using Rb-82 PET as the gold standard.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Radiation: SPECT/CT processed with Evolution for CardiacTM software"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Radiation",
                "InterventionName":"SPECT/CT processed with Evolution for CardiacTM software",
                "InterventionDescription":"SPECT/CT to be compared with PET/CT",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Evaluation of technology in SPECT"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"• Determine the accuracy of myocardial perfusion assessment using SPECT with AC/SC/RR compared to Rb-82 PET.",
                "PrimaryOutcomeDescription":"We are proposing a study to evaluate the accuracy of SPECT with the new technologies for attenuation correction (AC), scatter compensation (SC) and resolution recovery (RR) for the assessment of myocardial perfusion in patients with heart disease using Rb-82 perfusion PET as the gold standard for comparison.",
                "PrimaryOutcomeTimeFrame":"2 years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Determine the incremental benefit of AC/SC/RR compared to AC alone",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Evaluate the effect on accuracy of using software with RR to reduce the acquisition time to half of the standard time.",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Determine if using a registered diagnostic CT (PET) increases the accuracy of CT-based AC over the lower-quality Hawkeye CT (SPECT).",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Determine if using a single CT scan acquired at stress for attenuation correction of both stress and rest SPECT decreases the accuracy over using CT scans acquired separately at rest and stress.",
                "SecondaryOutcomeTimeFrame":"2 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nIntermediate to high risk patients with coronary artery disease who are scheduled for routine SPECT or PET perfusion imaging\n\nExclusion Criteria:\n\nPregnancy and breast feeding\nSevere narrowing (stenosis) of the aortic valve\nSevere heart failure",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Terrence D Ruddy, MD",
                "OverallOfficialAffiliation":"Ottawa Heart Institute Research Corporation",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University of Ottawa Heart Institute",
                "LocationCity":"Ottawa",
                "LocationState":"Ontario",
                "LocationZip":"K1Y 4W7",
                "LocationCountry":"Canada"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"22527797",
                "ReferenceType":"result",
                "ReferenceCitation":"Wells RG, Soueidan K, Vanderwerf K, Ruddy TD. Comparing slow- versus high-speed CT for attenuation correction of cardiac SPECT perfusion studies. J Nucl Cardiol. 2012 Aug;19(4):719-26. doi: 10.1007/s12350-012-9555-4. Epub 2012 Apr 21."
              },{
                "ReferencePMID":"23737161",
                "ReferenceType":"result",
                "ReferenceCitation":"Wells RG, Soueidan K, Timmins R, Ruddy TD. Comparison of attenuation, dual-energy-window, and model-based scatter correction of low-count SPECT to 82Rb PET/CT quantified myocardial perfusion scores. J Nucl Cardiol. 2013 Oct;20(5):785-96. doi: 10.1007/s12350-013-9738-7. Epub 2013 Jun 5."
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"No",
          "IPDSharingDescription":"This trial has concluded and the investigators have published from the available data."
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003324",
                "ConditionMeshTerm":"Coronary Artery Disease"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000003327",
                "ConditionAncestorTerm":"Coronary Disease"
              },{
                "ConditionAncestorId":"D000017202",
                "ConditionAncestorTerm":"Myocardial Ischemia"
              },{
                "ConditionAncestorId":"D000006331",
                "ConditionAncestorTerm":"Heart Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              },{
                "ConditionAncestorId":"D000001161",
                "ConditionAncestorTerm":"Arteriosclerosis"
              },{
                "ConditionAncestorId":"D000001157",
                "ConditionAncestorTerm":"Arterial Occlusive Diseases"
              },{
                "ConditionAncestorId":"D000014652",
                "ConditionAncestorTerm":"Vascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5129",
                "ConditionBrowseLeafName":"Coronary Artery Disease",
                "ConditionBrowseLeafAsFound":"Coronary Artery Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M18089",
                "ConditionBrowseLeafName":"Myocardial Ischemia",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5132",
                "ConditionBrowseLeafName":"Coronary Disease",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9126",
                "ConditionBrowseLeafName":"Ischemia",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3050",
                "ConditionBrowseLeafName":"Arteriosclerosis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3046",
                "ConditionBrowseLeafName":"Arterial Occlusive Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}