{ "FullStudy":{ "Rank":217880, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515631", "OrgStudyIdInfo":{ "OrgStudyId":"AG9031" }, "Organization":{ "OrgFullName":"Stanford University", "OrgClass":"OTHER" }, "BriefTitle":"Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record Review", "OfficialTitle":"Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record" }, "StatusModule":{ "StatusVerifiedDate":"September 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2007" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2018", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 27, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 28, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Jeffrey A. Feinstein", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Stanford University" }, "LeadSponsor":{ "LeadSponsorName":"Stanford University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Patients who have Alagille Syndrome (AGS) also frequently have blockages (or \"stenoses\") of their pulmonary arteries. Little is known about the degree or variability of these stenoses, or the effect of this disease on the right ventricle (the chamber of the heart which pumps blood to the lungs). This study will first quantify and describe pulmonary artery stenosis in patients with Alagille Syndrome. The study will also assess the effect of these stenoses on the right ventricle. The investigators hope to learn the degree and characteristics of pulmonary artery stenosis in Alagille Syndrome. The investigators also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille Syndrome. This information is critical in the management of patients with Alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. Furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well.", "DetailedDescription":"The investigators hope to learn the degree and characteristics of pulmonary artery stenosis in Alagille Syndrome. We also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille Syndrome. This information is critical in the management of patients with Alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. Furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well. For the third aim, we hope to learn about the different blood vessel abnormalities in the brain, and which abnormalities are most likely to lead to stroke." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Alagille Syndrome" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Case-Only" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Retrospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"25", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Study", "ArmGroupDescription":"Patients with alagille syndrome" } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Assessment of PA in Alagille Patient", "PrimaryOutcomeTimeFrame":"Open" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of Alagille Syndrome\n\nExclusion Criteria:\n\nNone", "HealthyVolunteers":"No", "Gender":"All", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] }, "StudyPopulation":"Patients with Alagille Syndrome. The age range will be from birth through adulthood. There will be no gender or ethnic limitations to study.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jeffrey Feinstein, MD, MPH", "OverallOfficialAffiliation":"Stanford University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Lucile Packard Children's Hospital at Stanford", "LocationCity":"Palo Alto", "LocationState":"California", "LocationZip":"94304", "LocationCountry":"United States" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000016738", "ConditionMeshTerm":"Alagille Syndrome" },{ "ConditionMeshId":"D000071079", "ConditionMeshTerm":"Stenosis, Pulmonary Artery" },{ "ConditionMeshId":"D000013577", "ConditionMeshTerm":"Syndrome" } ] }, 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},{ "ConditionAncestorId":"D000000015", "ConditionAncestorTerm":"Abnormalities, Multiple" },{ "ConditionAncestorId":"D000000013", "ConditionAncestorTerm":"Congenital Abnormalities" },{ "ConditionAncestorId":"D000030342", "ConditionAncestorTerm":"Genetic Diseases, Inborn" },{ "ConditionAncestorId":"D000001157", "ConditionAncestorTerm":"Arterial Occlusive Diseases" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14938", "ConditionBrowseLeafName":"Syndrome", "ConditionBrowseLeafAsFound":"Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5058", "ConditionBrowseLeafName":"Constriction, Pathologic", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M701", "ConditionBrowseLeafName":"Stenosis, Pulmonary Artery", "ConditionBrowseLeafAsFound":"Pulmonary Artery Stenosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M17682", "ConditionBrowseLeafName":"Alagille Syndrome", "ConditionBrowseLeafAsFound":"Alagille Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4602", "ConditionBrowseLeafName":"Cholestasis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4603", "ConditionBrowseLeafName":"Cholestasis, Intrahepatic", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3516", "ConditionBrowseLeafName":"Bile Duct Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3527", "ConditionBrowseLeafName":"Biliary Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9690", "ConditionBrowseLeafName":"Liver Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8001", "ConditionBrowseLeafName":"Heart Defects, Congenital", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12", "ConditionBrowseLeafName":"Congenital Abnormalities", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M19087", "ConditionBrowseLeafName":"Cardiovascular Abnormalities", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14", "ConditionBrowseLeafName":"Abnormalities, Multiple", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M22270", "ConditionBrowseLeafName":"Genetic Diseases, Inborn", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3046", "ConditionBrowseLeafName":"Arterial Occlusive Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T260", "ConditionBrowseLeafName":"Alagille Syndrome", "ConditionBrowseLeafAsFound":"Alagille Syndrome", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }