跳至主要内容
临床试验/NCT03173066
NCT03173066已完成1 期

Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年9月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
1
试验地点
1
主要终点
Pulmonary embolus

研究概览

简要总结

This proposal is based on findings from our previous work involving ferumoxytol-enhanced cardiac magnetic resonance angiography. The resolution of the pulmonary vasculature based on our previous imaging protocol was exceptional (PMID: 26786296). In the Partners Healthcare System between January 1, 2014 and January 1, 2015 there were 541 patients evaluated in Partners Healthcare-affiliated hospitals with a diagnosis of pulmonary embolism and acute or chronic kidney disease at the same visit between 01/01/2014 and 01/01/2015. Ventilation perfusion scanning was performed in 201 patients during this same time interval. Up to 63% of these patients in one year did not receive the diagnostic test of choice.

详细描述

Thromboembolic events in patients with chronic kidney disease are out of proportion to age matched controls occurring 2.34 times more frequently than in non-CKD patients (PMID 19561505). At the same time, patients with kidney disease are not offered the gold standard for pulmonary embolus diagnosis, i.e. CT angiography, for concern of acute dialysis to treat contrast-induced nephropathy. Ventilation perfusion scintigraphy (V/Q) is the preferred diagnostic test for patients with advanced CKD (glomerular filtration rate <30mL/min/m2) and suspicion of pulmonary embolus, but can not be utilized if pulmonary parenchyma contains interstitial edema or alveolar occlusion due to pneumonia. If diagnostic tools for pulmonary embolus are not available, patients are subject to the risk of empiric treatment to avoid life-threatening complications of untreated pulmonary embolus. For those patients with CKD that undergo CT angiography, they are placed at risk of initiating dialysis. If this occurs multiple financial costs are associated with dialysis catheter placement and acute hemodialysis. If a patient instead is evaluated with gadolinium-based contrast modalities, there is the risk of nephrogenic systemic fibrosis and the morbidity associated with this iatrogenic disease process.

Ferumoxytol-enhanced MRI could avoid the risk of iodinated contrast and gadolinium contrast and accelerate the diagnosis and treatment of patients with pulmonary embolus.

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a clinical suspicion for pulmonary embolus
  • estimated glomerular filtration rate (eGFR) <30mL/min/1.73m2
  • have been clinically disqualified from the use of iodine-based contrast studies, gadolinium-based contrast studies or nuclear-based detection studies

排除标准

  • received ferumoxytol in the previous six months
  • anaphylactic reaction to other intravenous iron formulations
  • calculated estimated glomerular filtration rate is >50mL/min/1.78m2
  • patients on dialysis with no residual renal function
  • pregnant women and nursing mothers. Standard screening will be used by
  • patients >65 years of age with BMI >45, and/or liver disease (Child-Pugh class C)

研究组 & 干预措施

Single Arm

Experimental

Patients with a clinical concern for pulmonary embolus but not able to receive iodinated contrast will be enrolled. Ferumoxytol will be administered as a contrast agent in coordination with magnetic resonance angiography to identify patency of the cardiopulmonary vasculature.

干预措施: Ferumoxytol (Drug)

结局指标

主要结局

Pulmonary embolus

时间窗: 1 year

Detection of pulmonary embolus with ferumoxytol-enhanced magnetic resonance angiography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Michael Siedlecki

Instructor in Medicine

Brigham and Women's Hospital

研究点 (1)

Loading locations...

相似试验