跳至主要内容
临床试验/NCT02875600
NCT02875600Unknown不适用

Magnetic Resonance Flow Measurements of Mesenteric Arteries and Veins and Portal Vein With Food Stimulation in Patients Suspected of Chronic Gastro-intestinal Ischemia

Erasmus Medical Center2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
试验地点
2
主要终点
Determination of difference in baseline MR flow measurements and post prandial MR flow

研究概览

简要总结

To determine the difference in baseline MR flow measurements and post-prandial MR flow measurements between patients diagnosed with CGI and patients not diagnosed with CGI.

详细描述

The diagnosis of chronic gastro-intestinal ischemia (CGI) remains a clinical challenge because this diagnosis is difficult to distinguish by the frequent incidence of chronic abdominal pain and asymptomatic stenosis of the mesenteric arteries1. The standard diagnostic work up includes medical history, anamnesis and physical examination, radiological imaging and a functional test as visible light spectroscopy (VLS)2-4 or tonometry5-7. A multidisciplinary team consisting of a gastroenterologist, a vascular surgeon and an interventional radiologist, all specialized in CGI, discusses all patients which results in an expert based consensus diagnosis. Currently, there is no specific test to diagnose CGI. In literature, Magnetic Resonance (MR) techniques are described by which the flow in the mesenteric vessels is measured pre- and post-prandial in healthy volunteers and CGI patients8-12. The flow in the mesenteric vessels increases post-prandial (hyperemia). However, this increase in post-prandial flow compared to pre-prandial appeared less in CGI patients compared to the healthy volunteers. In some CGI patients, even a decrease of the post-prandial compared to pre-prandial flow was seen. We might be able to distinguish patients with CGI from patients without CGI with MR flow measurements with food stimulation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suspected of CGI referred to our hospital for further analysis
  • Age ≥ 18 years
  • Patients who gave informed consent

排除标准

  • Age < 18 years
  • Unable to give informed consent
  • Contra-indications for MRI: a. Metal implants which cannot be removed. E.g. cardiac pacemakers/ICD, aneurysm clips, metal stents, artificial heart valve, cochlea/retinal implants, hearing aids, dentures with magnetic click system or with other metal accessories, tattoos with metallic dye, metal plates/pins/screws of bones, piercings b. Claustrophobia c. Inability to lie still for 1 hour to 1,5 hours
  • Other criteria the physician considers are not compatible with this study

结局指标

主要结局

Determination of difference in baseline MR flow measurements and post prandial MR flow

时间窗: 2.5 years

The difference in baseline MR flow measurements and post prandial MR flow measurements between patients diagnosed with CGI and patients not diagnosed with CGI (mL/min/kg)

次要结局

  • Wich vessel or combination of vessels differentiate best(2.5 years)
  • The severity of abdominal pain(20/30/40 minutes)
  • Determination of difference in MR flow measurements before and after treatment for CGI(2.5 years)

研究者

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

Trialbureau radiology

dr

Erasmus Medical Center

研究点 (2)

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