Measuring blood flow stress in infants' pulmonary veins

Calculating Wall Shear Stress in Pulmonary Veins of Infants Using Cardiac Magnetic Resonance Imaging: A Pilot Study

This study is testing a new way to measure blood flow in the veins of infants' hearts to see if it can help identify and treat a serious condition called pulmonary vein stenosis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: Children's Hospital of Philadelphia (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06440408 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include high-risk infants with moderate to severe bronchopulmonary dysplasia or those who have undergone surgical repair for total anomalous pulmonary venous connection.

Not a fit: Patients with congenital heart disease or those not receiving Ferumoxytol as part of their cardiac MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better screening and management of infants at risk for pulmonary vein stenosis.

How similar studies have performed: This approach of using FcMRI to calculate WSS in pediatric pulmonary veins is novel and has not been previously reported.

Eligibility criteria

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 moderate to severe BPD (group 1) or TAPVC s/p repair (group 2).
3. Weight \> 3 kg.
4. Undergoing non-contrast MRI for clinical reasons (group 1) or undergoing cMRI with ferumoxytol as part of clinical care (group 2).
5. 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 such as a known hypersensitivity to the drug, or a known diagnosis of iron overload.

Where this trial is running

Philadelphia, Pennsylvania

• 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

Conditions Pulmonary Vein Stenosis; Cardiac Magnetic Resonance Imaging; Wall Shear Stress