{
  "FullStudy":{
    "Rank":217742,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517425",
          "OrgStudyIdInfo":{
            "OrgStudyId":"11-5676"
          },
          "Organization":{
            "OrgFullName":"Scripps Translational Science Institute",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells",
          "OfficialTitle":"Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells",
          "Acronym":"iPSC"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2019",
          "OverallStatus":"Enrolling by invitation",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2025",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2030",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 2, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 4, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Eric Topol, MD",
            "ResponsiblePartyInvestigatorTitle":"Director, Scripps Translational Science Institute",
            "ResponsiblePartyInvestigatorAffiliation":"Scripps Translational Science Institute"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Scripps Translational Science Institute",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This research is being done to understand how changes in DNA may put people at risk for developing coronary artery disease. Stem cells will be made using cells from blood and/or skin biopsy samples. We are trying to understand which specific changes in DNA negatively impact a person's health."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Coronary Artery Disease"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Retrospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"200",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Cases",
                "ArmGroupDescription":"Subjects previously enrolled in the Scripps Genebank Study"
              },{
                "ArmGroupLabel":"Controls",
                "ArmGroupDescription":"Subjects previously enrolled in the Scripps Healthy Elderly Active Longevity (HEAL) Cohort"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"iPSC development",
                "PrimaryOutcomeDescription":"Develop methods of iPSC generation from patients with genomic risk.",
                "PrimaryOutcomeTimeFrame":"five years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nCases:\n\nPreviously enrolled in the CAD module of the Genebank at Scripps Clinic Registry\nEligible to have their blood drawn\nBe reliable, cooperative and willing to comply with all protocol-specified procedures\nAble to understand and grant informed consent\n\nControls:\n\nPreviously enrolled in the Healthy Elderly Active Longevity (HEAL) Cohort\nEligible to have their blood drawn\nBe reliable, cooperative and willing to comply with all protocol-specified procedures\nAble to understand and grant informed consent\n\nExclusion Criteria:\n\nUnwilling or unable to grant informed consent.\nHave a significant medical condition that in the Investigator's opinion may interfere with subject's study participation.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Subjects previously enrolled in the Scripps Genebank or Healthy Elderly Active Longevity (HEAL) Cohort",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Scripps Translational Science Institute",
                "LocationCity":"La Jolla",
                "LocationState":"California",
                "LocationZip":"92037",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "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"
              }
            ]
          }
        }
      }
    }
  }
}

