Calculating Wall Shear Stress in Infant Pulmonary Veins
ConditionPulmonary Vein Stenosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorChildren's Hospital of Philadelphia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Weight > 3 kg.
Undergoing cMRI with ferumoxytol as part of clinical care.
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.
Parental/guardian permission (informed consent).
Disqualifiers
Congenital heart disease (except small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies).
Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Patient not receiving ferumoxytol as part of their cMRI due to a known hypersensitivity to the drug, or a known diagnosis of iron overload.
Males or Females less than 12 months of age.
Trial design
Design model
Single group
Treatments tested in this trial
Ferumoxytol
DrugFerumoxytol will be used as a contrast agent for the cMRI
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Ferumoxytol enhanced cMRIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Wall Shear Stress level in infant pulmonary veins using cMRI
WSS (dyn/cm2) will be reported in each pulmonary vein using multiple modalities with data from the cMRI. This includes computational fluid dynamics, 4D-Flow and 4\*Mu\*v/r, where Mu is the viscosity of blood, r is the vessel radius, and v is the average velocity of blood.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov