Calculating Wall Shear Stress in Infant Pulmonary Veins

This study aims to understand pediatric pulmonary vein stenosis (PVS), a narrowing of blood vessels connecting the lungs to the heart. Researchers believe high Wall Shear Stress (WSS), a force on vein walls, might contribute to PVS. This study will use Ferumoxytol, a contrast agent, with Cardiac Magnetic Resonance Imaging (FcMRI) to see if WSS can be measured in infants' pulmonary veins. If successful, this method could help identify infants at risk for PVS and guide treatment. You may be eligible if you are under 18, weigh over 3 kg, and are already having an FcMRI as part of your medical care for other reasons, with a structurally normal heart. The study is currently unclear on its recruitment status.

Study design
This is a single-center, feasibility study involving 20 participants. It is an interventional study, meaning participants will receive a specific intervention.
What's involved
Participants will undergo a cMRI with ferumoxytol as part of their clinical care. The primary measurement of Wall Shear Stress will be taken at 12 months.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Wall Shear Stress, will be measured at 12 months.

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NCT06440408

Calculating Wall Shear Stress in Infant Pulmonary Veins

Recruiting
PHASE1Up to 18InterventionalDiagnostic
Children's Hospital of Philadelphia
~20 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Ferumoxytol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Wall Shear Stress level in infant pulmonary veins using cMRI
Measured over 12 months
Pulmonary Vein Stenosis
1 sites across 1 states
Pennsylvania1
  • Ryan Callahan, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

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  • Wall Shear Stress level in infant pulmonary veins using cMRI12 months

    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.