Calculating Wall Shear Stress in Infant Pulmonary Veins

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · May 30, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding a serious condition called pulmonary vein stenosis (PVS), which is when the blood vessels that carry blood from the lungs to the heart become narrow. This narrowing can be life-threatening and the exact cause is not known. Researchers believe that a factor called Wall Shear Stress (WSS), which is the pressure on the walls of these veins, may play a role in PVS. They want to see if they can measure WSS in the pulmonary veins of infants using a special type of MRI that includes a contrast agent called ferumoxytol. The goal is to find better ways to identify infants at risk for PVS and improve their treatment.

To participate in this study, infants under 12 months old who have certain medical conditions or healthy children under 18 years old may be eligible. Key criteria for healthy participants include having a normal heart structure and undergoing an MRI with ferumoxytol for clinical care. Families will need to give permission for their child to participate. Participants can expect to undergo an MRI scan, which is a safe and common procedure that allows doctors to see inside the body. This study is currently recruiting participants, and it aims to not only enhance understanding of PVS but also potentially improve screening and treatment for at-risk infants.

Gender

ALL

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.

Trial Officials