Pulmonary Vein Stenosis Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• Males or Females less than 18 years of age.

• Weight \> 3 kg.

• Undergoing cMRI with ferumoxytol as part of clinical care.

• 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.

• Parental/guardian permission (informed consent).

• Males or Females less than 12 months of age.

• Diagnosis of moderate to severe BPD (group 1) or TAPVC s/p repair (group 2).

• Weight \> 3 kg.

• Undergoing non-contrast MRI for clinical reasons (group 1) or undergoing cMRI with ferumoxytol as part of clinical care (group 2).

• Parental/guardian permission (informed consent).

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Ryan Callahan, MD
callahanr2@chop.edu
267-426-2957
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2027-03
Participants
Target number of participants: 20
Treatments
Experimental: Ferumoxytol enhanced cMRI
A one time dose of Ferumoxytol will be administered prior to the cMRI in order to enhance the images. A dose of 4 mg/kg (max dose 510 mg) administered at a concentration of 8 mg/mL (in saline) will be used for this study. If the volume being administered is less than 6 mL, this is diluted with 3 mL of normal saline prior to administration. The drug is given over 15 minutes intravenously through a central or peripheral line. The drug is given at least 15 minutes prior to cardiac imaging.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia

This content was sourced from clinicaltrials.gov