Calculating Wall Shear Stress in Infant Pulmonary Veins

Conditions

• Pulmonary Vein Stenosis

Eligibility Criteria

Sex

ALL

Age

N/A - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Ferumoxytol — DRUG
  Ferumoxytol will be used as a contrast agent for the cMRI

Study Details

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.

Key Dates

Start date

Sep 30, 2024

Status verified

Aug 2025

Primary completion

Sep 30, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Ferumoxytol enhanced cMRI
  A one time dose of Ferumoxytol will be administered prior to the cMRI in order to enhance the images. A dose of 4 mg/kg (max dose 510 mg) administered at a concentration of 8 mg/mL (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.

Primary Outcome Measure

Wall Shear Stress level in infant pulmonary veins using cMRI [ Time Frame: 12 months ]

Central Contacts

• Ryan Callahan, MD
  267-426-2957
  [email protected]

Locations (1)

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