[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549926":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":30,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":30,"maxAge":60,"enrollmentInfo":61,"targetDuration":30,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ferumoxytol enhanced cMRI","EXPERIMENTAL","A one time dose of Ferumoxytol will be administered prior to the cMRI in order to enhance the images. A dose of 4 mg\u002Fkg (max dose 510 mg) administered at a concentration of 8 mg\u002FmL (in saline) will be used for this study. If the volume being administered is less than 6 mL, this is diluted with 3 mL of normal saline prior to administration. The drug is given over 15 minutes intravenously through a central or peripheral line. The drug is given at least 15 minutes prior to cardiac imaging.",[13],"Drug: Ferumoxytol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Ferumoxytol","Ferumoxytol will be used as a contrast agent for the cMRI",[9],[21],"Feraheme",[23],{"name":24,"affiliation":5,"role":25},"Ryan Callahan, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","267-426-2957",null,"callahanr2@chop.edu",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Children's Hospital of Philadelphia","RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-75.16362,39.95238,{"lat":45,"lon":44},[48],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},{"type":25,"investigatorFullName":24,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Associate Professor of Pediatrics","100549926","phase-1-calculating-wall-shear-stress-in-infant-pulmonary-veins-100549926",false,"NCT06440408","Calculating Wall Shear Stress in Infant Pulmonary Veins","Calculating Wall Shear Stress in Pulmonary Veins of Infants Using Cardiac Magnetic Resonance Imaging: A Pilot Study","PVS-WSS","Normal (Controls) Subjects Inclusion Criteria\n\n1. Males or Females less than 18 years of age.\n2. Weight \\> 3 kg.\n3. Undergoing cMRI with ferumoxytol as part of clinical care.\n4. Structurally normal heart (by echocardiography) with exception of small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies.\n5. Parental\u002Fguardian permission (informed consent).\n\nNormal (Controls) Subjects Exclusion Criteria\n\n1. Congenital heart disease (except small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies).\n2. Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.\n3. Patient not receiving ferumoxytol as part of their cMRI due to a known hypersensitivity to the drug, or a known diagnosis of iron overload.\n\nHigh-Risk Subject Inclusion Criteria\n\n1. Males or Females less than 12 months of age.\n2. Diagnosis of severe BPD (group 1) or TAPVC s\u002Fp repair (group 2).\n3. Weight \\> 3 kg.\n4. Receiving respiratory support with an invasive airway (tracheostomy or endotracheal tube) (group 1 only).\n5. Undergoing cMRI with ferumoxytol as part of clinical care (group 2 only).\n6. Parental\u002Fguardian permission (informed consent).\n\nHigh-Risk Subject Exclusion Criteria\n\n1. Congenital heart disease with single ventricle physiology.\n2. Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.\n3. Patient has a contraindication to ferumoxytol or any intravenous iron product such as a known hypersensitivity to the drug, or a known diagnosis of iron overload.","ALL","18 Years",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","The purpose of this study is to better understand pediatric pulmonary vein stenosis (PVS), which is the narrowing of blood vessels that connect the lungs to the heart. PVS is a life-threatening disease without a clear cause. The investigators think patients who develop PVS have an increased Wall Shear Stress (WSS) level in the pulmonary veins, which is the force placed on the walls of the veins. This study will determine if WSS can be calculated in the pulmonary veins of infants using Ferumoxytol enhanced Cardiac Magnetic Resonance Imaging (FcMRI). If possible, the investigators aim to use FcMRI to better screen patients at risk of PVS and to help guide therapy in patients with PVS.",[69],"Pulmonary Vein Stenosis",[71,72],"Cardiac Magnetic Resonance Imaging","Wall Shear Stress","2026-08-03",{"date":75,"type":76},"2026-08-05","ACTUAL",{"date":78,"type":76},"2024-09-30",{"date":80,"type":63},"2028-06",{"name":5,"class":6},1]