Nctid:
NCT06234410
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}, {"id"=>"M19506", "name"=>"Myocardial Ischemia", "relevance"=>"LOW"}, {"id"=>"M6546", "name"=>"Coronary Artery Disease", "relevance"=>"LOW"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "relevance"=>"LOW"}, {"id"=>"M6549", "name"=>"Coronary Disease", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITH_DNA", "description"=>"Serum and plasma (including for potential genetic analysis) will be taken from participants and stored."}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>332}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2032-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-05", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-07", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2032-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Number of participants who suffer a clinically significant acute kidney injury following study CTCA scan", "timeFrame"=>"From time of CTCA scan to 28 days follow-up", "description"=>"Unexpected progression to dialysis (haemodialysis or peritoneal dialysis) within 28 days of study CTCA scan"}, {"measure"=>"Number of participants who have clinically significant abnormal non-cardiac findings on study CTCA scan", "timeFrame"=>"From time of CTCA scan to 12 months follow-up", "description"=>"Abnormal non-cardiac findings (e.g., lung mass), not related to a pre-existing condition and requiring further investigation"}], "primaryOutcomes"=>[{"measure"=>"Number of participants who have either a myocardial infarction or cardiovascular death", "timeFrame"=>"From time of CTCA scan to 36- and 60-months follow-up", "description"=>"The first event of myocardial infarction or cardiovascular death"}], "secondaryOutcomes"=>[{"measure"=>"Number of participants who have a fatal or non-fatal myocardial infarction", "timeFrame"=>"From time of CTCA scan to 36- and 60-months follow-up", "description"=>"The first event of myocardial infarction (MI). MI will be defined according to the 4th Universal Definition of Myocardial Infarction."}, {"measure"=>"Number of participants who are hospitalised due to any cardiovascular event", "timeFrame"=>"From time of CTCA scan to 36- and 60-months follow-up", "description"=>"Hospital admission due to any cardiovascular event (including myocardial infarction, heart failure, stroke, or any other cardiovascular disease)"}, {"measure"=>"Number of participants who die (all-cause death)", "timeFrame"=>"From time of CTCA scan to 36- and 60-months follow-up", "description"=>"Death due to any cause"}, {"measure"=>"Number of participants who have a cardiovascular death", "timeFrame"=>"From time of CTCA scan to 36- and 60-months follow-up", "description"=>"Death due to a cardiovascular cause (including myocardial infarction, heart failure, stroke, or any other cardiovascular disease)"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Coronary artery disease", "Kidney transplantation", "Cardiovascular risk assessment", "Heart disease", "Chronic kidney disease"], "conditions"=>["Cardiovascular Diseases", "Kidney Transplant; Complications"]}, "descriptionModule"=>{"briefSummary"=>"Cardiovascular disease (for example, heart attack, stroke, heart failure) is the commonest complication of kidney failure. Kidney transplantation reduces cardiovascular risk but cardiovascular disease remains the commonest cause of death in patients following transplantation.\n\nCurrent strategies to assess patient's cardiovascular risk prior to kidney transplantation do not identify those at highest risk and do not improve outcomes.\n\nThis study will use a heart scan known as computed tomography coronary angiography (CTCA) to see whether this scan can identify patients at highest risk of future cardiovascular disease prior to transplantation. Studies have shown it is able to do this in patients with normal kidney function.\n\nThe aim of this study is to develop CTCA as an effective tool to risk stratify patients prior to kidney transplantation."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients on the kidney transplant waitlist", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Has kidney failure and is on the waitlist for a kidney transplant\n* Age 16 years and over\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Contraindication to CT scanning, including contrast allergy\n* Patients being considered for a simultaneous kidney-pancreas, kidney-liver and/or kidney-islet transplantation\n* Inability to give informed consent"}, "identificationModule"=>{"nctId"=>"NCT06234410", "acronym"=>"CRAFT-CTCA", "briefTitle"=>"Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Edinburgh"}, "officialTitle"=>"Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation", "orgStudyIdInfo"=>{"id"=>"TCS/22/09"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients waitlisted for kidney transplantation", "description"=>"Patients who have been placed on the waiting list for a kidney transplant within Scotland", "interventionNames"=>["Radiation: Computed tomography coronary angiography (CTCA)"]}], "interventions"=>[{"name"=>"Computed tomography coronary angiography (CTCA)", "type"=>"RADIATION", "description"=>"Single CTCA scan prior to kidney transplantation", "armGroupLabels"=>["Patients waitlisted for kidney transplantation"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"EH16 4SA", "city"=>"Edinburgh", "state"=>"Lothian", "status"=>"RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Gavin B Chapman, MBChB", "role"=>"CONTACT", "email"=>"gchapma2@ed.ac.uk", "phone"=>"00447713349318"}, {"name"=>"Gavin B Chapman, MBChB", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Neeraj Dhaun, MBChB", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Nicholas Mills, MBChB", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Michelle Williams, MBChB", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Royal Infirmary of Edinburgh", "geoPoint"=>{"lat"=>55.95206, "lon"=>-3.19648}}, {"zip"=>"G51 4TF", "city"=>"Glasgow", "status"=>"NOT_YET_RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Patrick Mark, MBChB", "role"=>"CONTACT", "email"=>"patrick.mark@glasgow.ac.uk"}, {"name"=>"Patrick Mark, MBChB", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Rajan Patel, MBChB", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Gavin Chapman, MBChB", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Giles Roditi, MBChB", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Queen Elizabeth Hospital", "geoPoint"=>{"lat"=>55.86515, "lon"=>-4.25763}}], "centralContacts"=>[{"name"=>"Gavin B Chapman, MBChB", "role"=>"CONTACT", "email"=>"gchapma2@ed.ac.uk", "phone"=>"00447713349318"}, {"name"=>"Neeraj Dhaun, MBChB", "role"=>"CONTACT", "email"=>"bean.dhaun@ed.ac.uk"}], "overallOfficials"=>[{"name"=>"Neeraj Dhaun, MBChB", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Edinburgh"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"YES", "description"=>"Following publication of the primary paper, a deidentified individual participant data set will be will be made available for data sharing purposes, subject to necessary governance approvals. Access to the deidentified dataset will be under a controlled access model."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Edinburgh", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Chief Scientist Office of the Scottish Government", "class"=>"OTHER_GOV"}, {"name"=>"University of Glasgow", "class"=>"OTHER"}, {"name"=>"NHS Lothian", "class"=>"OTHER_GOV"}, {"name"=>"NHS Greater Glasgow and Clyde", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
