Actively Recruiting

Phase 1
Age: 0 - 18Years
All Genders
NCT06440408

Calculating Wall Shear Stress in Infant Pulmonary Veins

Led by Children's Hospital of Philadelphia · Updated on 2025-08-20

20

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Calculating Wall Shear Stress in Infant Pulmonary Veins

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females less than 18 years of age
  • Weight greater than 3 kg
  • Undergoing cMRI with ferumoxytol as part of clinical care (controls)
  • Structurally normal heart except for small left to right shunts, isolated valve pathology, anomalous coronary arteries, or extracardiac vascular anomalies (controls)
  • Parental or guardian permission (informed consent)
  • Males or females less than 12 months of age (high-risk group)
  • Diagnosis of moderate to severe bronchopulmonary dysplasia or postoperative repair of total anomalous pulmonary venous connection (high-risk group)
  • Undergoing non-contrast MRI for clinical reasons (group 1) or cMRI with ferumoxytol (group 2)
Not Eligible

You will not qualify if you...

  • Congenital heart disease except small left to right shunts, isolated valve pathology, anomalous coronary arteries, or extracardiac vascular anomalies (controls)
  • Known hypersensitivity to ferumoxytol or iron overload
  • Single ventricle physiology congenital heart disease (high-risk group)
  • Non-compliance with study schedules or procedures as determined by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

R

Ryan Callahan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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