Calculating Wall Shear Stress in Pulmonary Veins of Infants Using Cardiac Magnetic Resonance Imaging: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Wall Shear Stress level in infant pulmonary veins using cMRI
研究概览
简要总结
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.
详细描述
Background:
The mechanism of pediatric intraluminal pulmonary vein stenosis (PVS) remains unknown. It is hypothesized that elevated wall shear stress (WSS) as a result of excessive pulmonary blood flow (left to right shunts) and/or pulmonary vein distortion from surrounding anatomy contributes to the neo-intimal proliferation. Calculating WSS in pediatric pulmonary veins using ferumoxytol enhanced cardiac magnetic resonance (FcMRI) has not been reported and would represent a novel method of evaluation.
Objectives:
The primary objective is to determine the feasibility of calculating WSS in infant pulmonary veins using FcMRI. The secondary objective is to determine the magnitude and variability of WSS in pulmonary veins among high-risk patients and normal controls.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal (Controls) Subjects Inclusion Criteria
- •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).
- •Normal (Controls) Subjects
排除标准
- •Congenital heart disease (except small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies).
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- •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
- •Males or Females less than 12 months of age.
- •Diagnosis of severe BPD (group 1) or TAPVC s/p repair (group 2).
- •Weight > 3 kg.
- •Receiving respiratory support with an invasive airway (tracheostomy or endotracheal tube) (group 1 only).
- •Undergoing cMRI with ferumoxytol as part of clinical care (group 2 only).
- •Parental/guardian permission (informed consent).
- •High-Risk Subject Exclusion Criteria
- •Congenital heart disease with single ventricle physiology.
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- •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.
研究组 & 干预措施
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.
干预措施: Ferumoxytol (Drug)
结局指标
主要结局
Wall Shear Stress level in infant pulmonary veins using cMRI
时间窗: 12 months
WSS (dyn/cm2) will be reported in each pulmonary vein using multiple modalities with data from the cMRI. This includes computational fluid dynamics, 4D-Flow and 4\*Mu\*v/r, where Mu is the viscosity of blood, r is the vessel radius, and v is the average velocity of blood.
次要结局
未报告次要终点
研究者
Ryan Callahan, MD
Associate Professor of Pediatrics
Children's Hospital of Philadelphia