{
  "FullStudy":{
    "Rank":217639,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518777",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Pro00006818"
          },
          "Organization":{
            "OrgFullName":"The Methodist Hospital System",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Reducing Radioisotope Dose: the Half-Dose CZT Study",
          "OfficialTitle":"Reducing Radioisotope Dose in Regadenoson SPECT Myocardial Perfusion Imaging: Comparison of Half-Dose Scans Using a Novel Solid-State-Detector Dedicated Cardiac Camera to Full Dose Scans Acquired On Standard Equipment"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 16, 2016",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 16, 2016",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 23, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 4, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 6, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"S.M.Chang, MD",
            "ResponsiblePartyInvestigatorTitle":"Sponsor-Investigator/Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"The Methodist Hospital System"
          },
          "LeadSponsor":{
            "LeadSponsorName":"S.M.Chang, MD",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"The Methodist Hospital System",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a pilot study to see whether cardiac imaging can be performed using half the standard dose of radioisotope.",
          "DetailedDescription":"The aim of this study is to compare the image quality of the half radioisotope dose scans obtained using a CZT (cadmium zinc telluride) camera with scans acquired using a standard of care imaging protocol/radioisotope dose performed on a traditional (conventional) camera.\n\nThe proposed strategy of a half dose/extended time protocol with the CZT camera should yield a similar count activity and consequently image quality equivalent to that detected by a conventional SPECT system."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Coronary Artery Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Coronary Artery Disease"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"74",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Half-dose isotope for NuclearStressTest",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Intervention is Nuclear stress test of the heart. Single-arm of this study \"Half-dose of isotope for Nuclear stress test\" is group of study subjects who will do Research Nuclear stress test with half-dose of isotope that normally used for routine Nuclear stress test. Isotope is the tracer CZT (cadmium zinc telluride) that used for Nuclear stress test routinely to see the function of arteries of the heart. Patients with suspected Coronary Artery Disease who meet entry criteria undergo a research nuclear stress test using a decreased dose of isotope, using a new camera.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Half-dose isotope for NuclearStressTest"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Half-dose isotope for NuclearStressTest",
                "InterventionDescription":"Half-dose of tracer or radioisotope will be used for Nuclear stress test of the heart. This is imaging test of the heart to see the function of arteries of the heart.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Half-dose isotope for NuclearStressTest"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "SPECT using CZT"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Image quality of the half-dose CZT versus full dose scans",
                "PrimaryOutcomeTimeFrame":"1 Week"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Total radiation dose/exposure of the half-dose CZT vs. full dose scans",
                "SecondaryOutcomeTimeFrame":"1 Week"
              },{
                "SecondaryOutcomeMeasure":"Total myocardial count activity and count rates obtained during each scan",
                "SecondaryOutcomeTimeFrame":"1 Week"
              },{
                "SecondaryOutcomeMeasure":"Agreement between the half-dose CZT vs. full dose scans on the presence and extent of fixed or reversible defects on a per-patient and vessel basis",
                "SecondaryOutcomeTimeFrame":"1 Week"
              },{
                "SecondaryOutcomeMeasure":"Agreement between the half-dose vs. full dose scans on gated data such as EF, left ventricular (LV) end-diastolic volume, LV end-systolic volume",
                "SecondaryOutcomeTimeFrame":"1 Week"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\n≥ 18 years of age and referred for a clinically-indicated stress SPECT MPI study\nsuspected or known coronary artery disease\nwritten informed consent\n\nExclusion Criteria:\n\nEvidence of a normal baseline scan after at least 50% of the protocol acquired baseline scans have been interpreted as being normal\nParticipation in another investigational study within the preceding month\nPregnant and/or breast-feeding female\nECG evidence of left bundle branch block or paced rhythm\nEvidence of non-ischemic cardiomyopathy\nPresence of hypertrophic cardiomyopathy and/or severe valvular heart disease\nSevere claustrophobia or inability to lie flat for 20 minutes (the anticipated amount of time to complete the procedure)\nKnown allergy to technetium-99m\nPotential contraindications to regadenoson use, due to severe lung disease; severe bradycardia (heart rate < 40 beats/min); second- or third degree atrioventricular heart block; sick sinus syndrome; long QT syndrome; severe hypotension; or decompensated heart failure.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"90 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Su Min Chang, MD",
                "OverallOfficialAffiliation":"The Methodist Hospital System",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Houston Methodist Hospital",
                "LocationCity":"Houston",
                "LocationState":"Texas",
                "LocationZip":"77030",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"15052249",
                "ReferenceType":"background",
                "ReferenceCitation":"Shaw LJ, Iskandrian AE. Prognostic value of gated myocardial perfusion SPECT. J Nucl Cardiol. 2004 Mar-Apr;11(2):171-85. Review."
              },{
                "ReferencePMID":"17174798",
                "ReferenceType":"background",
                "ReferenceCitation":"Henzlova MJ, Cerqueira MD, Mahmarian JJ, Yao SS; Quality Assurance Committee of the American Society of Nuclear Cardiology. Stress protocols and tracers. J Nucl Cardiol. 2006 Nov;13(6):e80-90."
              },{
                "ReferencePMID":"17846343",
                "ReferenceType":"background",
                "ReferenceCitation":"Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. Review."
              },{
                "ReferencePMID":"17635892",
                "ReferenceType":"background",
                "ReferenceCitation":"Einstein AJ, Henzlova MJ, Rajagopalan S. Estimating risk of cancer associated with radiation exposure from 64-slice computed tomography coronary angiography. JAMA. 2007 Jul 18;298(3):317-23."
              },{
                "ReferencePMID":"19710483",
                "ReferenceType":"background",
                "ReferenceCitation":"Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, Shah ND, Nasir K, Einstein AJ, Nallamothu BK. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med. 2009 Aug 27;361(9):849-57. doi: 10.1056/NEJMoa0901249."
              },{
                "ReferencePMID":"21638151",
                "ReferenceType":"background",
                "ReferenceCitation":"Fazel R, Shaw LJ. Radiation exposure from radionuclide myocardial perfusion imaging: concerns and solutions. J Nucl Cardiol. 2011 Aug;18(4):562-5. doi: 10.1007/s12350-011-9403-y. Review."
              },{
                "ReferencePMID":"20008999",
                "ReferenceType":"background",
                "ReferenceCitation":"Herzog BA, Buechel RR, Katz R, Brueckner M, Husmann L, Burger IA, Pazhenkottil AP, Valenta I, Gaemperli O, Treyer V, Kaufmann PA. Nuclear myocardial perfusion imaging with a cadmium-zinc-telluride detector technique: optimized protocol for scan time reduction. J Nucl Med. 2010 Jan;51(1):46-51. doi: 10.2967/jnumed.109.065532. Epub 2009 Dec 15."
              },{
                "ReferencePMID":"20107783",
                "ReferenceType":"background",
                "ReferenceCitation":"Buechel RR, Herzog BA, Husmann L, Burger IA, Pazhenkottil AP, Treyer V, Valenta I, von Schulthess P, Nkoulou R, Wyss CA, Kaufmann PA. Ultrafast nuclear myocardial perfusion imaging on a new gamma camera with semiconductor detector technique: first clinical validation. Eur J Nucl Med Mol Imaging. 2010 Apr;37(4):773-8. doi: 10.1007/s00259-009-1375-7. Epub 2010 Jan 27. Erratum in: Eur J Nucl Med Mol Imaging. 2011 Jun;38(6):1172."
              },{
                "ReferencePMID":"19688410",
                "ReferenceType":"background",
                "ReferenceCitation":"Esteves FP, Raggi P, Folks RD, Keidar Z, Askew JW, Rispler S, O'Connor MK, Verdes L, Garcia EV. Novel solid-state-detector dedicated cardiac camera for fast myocardial perfusion imaging: multicenter comparison with standard dual detector cameras. J Nucl Cardiol. 2009 Nov-Dec;16(6):927-34. doi: 10.1007/s12350-009-9137-2. Epub 2009 Aug 18."
              },{
                "ReferencePMID":"21068188",
                "ReferenceType":"background",
                "ReferenceCitation":"Gimelli A, Bottai M, Giorgetti A, Genovesi D, Kusch A, Ripoli A, Marzullo P. Comparison between ultrafast and standard single-photon emission CT in patients with coronary artery disease: a pilot study. Circ Cardiovasc Imaging. 2011 Jan;4(1):51-8. doi: 10.1161/CIRCIMAGING.110.957399. Epub 2010 Nov 10."
              },{
                "ReferencePMID":"21528422",
                "ReferenceType":"background",
                "ReferenceCitation":"Duvall WL, Croft LB, Ginsberg ES, Einstein AJ, Guma KA, George T, Henzlova MJ. Reduced isotope dose and imaging time with a high-efficiency CZT SPECT camera. J Nucl Cardiol. 2011 Oct;18(5):847-57. doi: 10.1007/s12350-011-9379-7. Epub 2011 Apr 29."
              },{
                "ReferencePMID":"21638154",
                "ReferenceType":"background",
                "ReferenceCitation":"Duvall WL, Sweeny JM, Croft LB, Barghash MH, Kulkarni NK, Guma KA, Henzlova MJ. Comparison of high efficiency CZT SPECT MPI to coronary angiography. J Nucl Cardiol. 2011 Aug;18(4):595-604. doi: 10.1007/s12350-011-9382-z. Epub 2011 Jun 3."
              },{
                "ReferencePMID":"15295415",
                "ReferenceType":"background",
                "ReferenceCitation":"Mahmarian JJ, Shaw LJ, Olszewski GH, Pounds BK, Frias ME, Pratt CM; INSPIRE Investigators. Adenosine sestamibi SPECT post-infarction evaluation (INSPIRE) trial: A randomized, prospective multicenter trial evaluating the role of adenosine Tc-99m sestamibi SPECT for assessing risk and therapeutic outcomes in survivors of acute myocardial infarction. J Nucl Cardiol. 2004 Jul-Aug;11(4):458-69."
              },{
                "ReferencePMID":"19154964",
                "ReferenceType":"background",
                "ReferenceCitation":"ICRP. Radiation dose to patients from radiopharmaceuticals. Addendum 3 to ICRP Publication 53. ICRP Publication 106. Approved by the Commission in October 2007. Ann ICRP. 2008;38(1-2):1-197. doi: 10.1016/j.icrp.2008.08.003."
              },{
                "ReferencePMID":"18082557",
                "ReferenceType":"background",
                "ReferenceCitation":"The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1-332."
              },{
                "ReferencePMID":"10840563",
                "ReferenceType":"background",
                "ReferenceCitation":"Radiation dose to patients from radiopharmaceuticals (addendum 2 to ICRP publication 53). Ann ICRP. 1998;28(3):1-126."
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"Undecided",
          "IPDSharingDescription":"No."
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003324",
                "ConditionMeshTerm":"Coronary Artery Disease"
              },{
                "ConditionMeshId":"D000017202",
                "ConditionMeshTerm":"Myocardial Ischemia"
              },{
                "ConditionMeshId":"D000003327",
                "ConditionMeshTerm":"Coronary Disease"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "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",
                "ConditionBrowseLeafAsFound":"Coronary Artery Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5132",
                "ConditionBrowseLeafName":"Coronary Disease",
                "ConditionBrowseLeafAsFound":"Coronary Artery Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "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"
              }
            ]
          }
        }
      }
    }
  }
}