Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Nov 3, 1999

Nctid: NCT00001874

Payload: {"FullStudy"=>{"Rank"=>491096, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"April 26, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000002318", "ConditionMeshTerm"=>"Cardiovascular Diseases"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "EnrollmentInfo"=>{"EnrollmentCount"=>"400"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"February 22, 1999"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"August 3, 2009", "CompletionDateStruct"=>{"CompletionDate"=>"August 3, 2009", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"June 30, 2017", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"July 2, 2017", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"August 3, 2009", "PrimaryCompletionDateType"=>"Actual"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Imaging", "Spectroscopy", "MRI", "Cardiovascular", "Technical Development", "Safety", "Gadolinium", "Heart", "Toxicity", "Adverse Events", "Normal Volunteer"]}, "ConditionList"=>{"Condition"=>["Cardiovascular Disease", "Healthy"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"7928216", "ReferenceType"=>"background", "ReferenceCitation"=>"Frank JA, Mattay VS, Duyn J, Sobering G, Barrios FA, Zigun J, Sexton R, Kwok P, Woo J, Moonen C, et al. Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentetate-dimeglumine-enhanced dynamic magnetic resonance imaging. Invest Radiol. 1994 Jun;29 Suppl 2:S157-60. doi: 10.1097/00004424-199406001-00052. No abstract available."}, {"ReferencePMID"=>"7862963", "ReferenceType"=>"background", "ReferenceCitation"=>"Mattay VS, Weinberger DR, Barrios FA, Sobering GS, Kotrla KJ, van Gelderen P, Duyn JH, Sexton RH, Moonen CT, Frank JA. Brain mapping with functional MR imaging: comparison of gradient-echo--based exogenous and endogenous contrast techniques. Radiology. 1995 Mar;194(3):687-91. doi: 10.1148/radiology.194.3.7862963."}, {"ReferencePMID"=>"1889423", "ReferenceType"=>"background", "ReferenceCitation"=>"Niendorf HP, Dinger JC, Haustein J, Cornelius I, Alhassan A, Clauss W. Tolerance data of Gd-DTPA: a review. Eur J Radiol. 1991 Jul-Aug;13(1):15-20. doi: 10.1016/0720-048x(91)90049-2."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Magnetic resonance imaging (MRI) and spectroscopy are diagnostic tools that create high quality images of the human body without the use of X-ray (radiation). MRI uses different levels of magnetic fields to create images of the body and organs. Occasionally, researchers will give patients undergoing a MRI an injection of a contrast substance. The contrast substance works by brightening areas of the magnetic resonance image.\n\nIn this study researchers plan to use magnetic resonance imaging with contrast substances and exercise on normal volunteers in order to evaluate different aspects of its performance. Information gathered from this study may be used to develop more specific research studies involving MRI....", "DetailedDescription"=>"Technical evaluation of magnetic resonance imaging and spectroscopy will be performed on normal volunteers. These studies will be conducted in the NIH MRI systems located in Suburban Hospital in Bethesda, Maryland. These studies may involve the intravenous administration of commercially available MR contrast media and exercise. The results will be used to evaluate the performance of various pulse sequences, gradient coils, and RF coils on human subjects and will provide essential ground work for specific patient protocols."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nAny normal volunteer above the age 18 who is capable of giving informed consent will be included.\n\nEXCLUSION CRITERIA:\n\nA subject will be excluded if he/she has a contradiction to MR scanning.\n\nBrain aneurysm clip\nImplanted neural stimulator\nImplanted cardiac pacemaker implanted defibrillator\nCochlear implant\nOcular foreign body (e.g. metal shavings)\nInsulin pump\nPregnant women (when uncertain, subjects will undergo urine or blood testing).\nKidney\nParalyzed hemidiaphragm\nMorbid obesity\nClaustrophobia\nAny condition in the PI's judgement which present unncessary risk\n\nEXCLUSION CRITERIA FOR GADOLINIUM ENHANCED STUDIES:\n\nLactating women\nSubjects with hemoglobinopathies\nAsthma\nRenal or hepatic disease\n\nSubjects will be excluded if it is deemed that they have a condition that would preclude their use for technical development (e.g. paralyzed hemidiaphragm, morbid obesity, claustrophobia etc.) or present unnecessary risk (e.g. pregnancy, surgery of uncertain type, etc.).\n\nLactating women and subjects with hemoglobinopathies, asthma, or renal or hepatic disease will be excluded from studies involving the adminstration of contrast agents."}, "IdentificationModule"=>{"NCTId"=>"NCT00001874", "BriefTitle"=>"Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy", "OrgStudyIdInfo"=>{"OrgStudyId"=>"990048"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"99-H-0048"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20814", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Suburban Hospital"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}