Measuring blood flow stress in infants' pulmonary veins

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate pediatric pulmonary vein stenosis (PVS), a serious condition characterized by the narrowing of blood vessels connecting the lungs to the heart. Researchers hypothesize that elevated wall shear stress (WSS) in the pulmonary veins contributes to PVS. Using Ferumoxytol enhanced Cardiac Magnetic Resonance Imaging (FcMRI), the study will assess the feasibility of calculating WSS in infants. The study will involve high-risk infants and normal controls to compare WSS levels and variability. The ultimate goal is to improve screening and treatment strategies for infants at risk of PVS.

Why it matters

Who can join: the full rules

Normal (Controls) Subjects Inclusion Criteria

1. Males or Females less than 18 years of age.
2. Weight \> 3 kg.
3. Undergoing cMRI with ferumoxytol as part of clinical care.
4. 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.
5. Parental/guardian permission (informed consent).

Normal (Controls) Subjects Exclusion Criteria

1. Congenital heart disease (except small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies).
2. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
3. Patient not receiving ferumoxytol as part of their cMRI due to a known hypersensitivity to the drug, or a known diagnosis of iron overload.

High-Risk Subject Inclusion Criteria

1. Males or Females less than 12 months of age.
2. Diagnosis of severe BPD (group 1) or TAPVC s/p repair (group 2).
3. Weight \> 3 kg.
4. Receiving respiratory support with an invasive airway (tracheostomy or endotracheal tube) (group 1 only).
5. Undergoing cMRI with ferumoxytol as part of clinical care (group 2 only).
6. Parental/guardian permission (informed consent).

High-Risk Subject Exclusion Criteria

1. Congenital heart disease with single ventricle physiology.
2. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
3. Patient has a contraindication to ferumoxytol or any intravenous iron product such as a known hypersensitivity to the drug, or a known diagnosis of iron overload.

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Ryan Callahan, MD — Children's Hospital of Philadelphia
• Study coordinator: Ryan Callahan, MD
• Email: callahanr2@chop.edu
• Phone: 267-426-2957

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.