Actively Recruiting
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
Eligibility Criteria
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)
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
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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