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Magnetic Resonance Flow Measurements of Mesenteric Arteries and Veins and Portal Vein

2021年3月8日 更新者:Trialbureau radiology、Erasmus Medical Center

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

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.

研究概览

地位

未知

条件

详细说明

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.

研究类型

介入性

注册 (预期的)

62

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Zuid Holland
      • Rotterdam、Zuid Holland、荷兰、3015CE
        • 招聘中
        • ErasmusMC
        • 首席研究员:
          • Mohamed Ouhlous, MD
        • 副研究员:
          • Louisa van DIjk, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Patients suspected of CGI referred to our hospital for further analysis
  2. Age ≥ 18 years
  3. Patients who gave informed consent

Exclusion Criteria:

  1. Age < 18 years
  2. Unable to give informed consent
  3. Pregnancy
  4. 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
  5. Other criteria the physician considers are not compatible with this study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Nutri drink
MRI flow measurements of mesenterial vessels and portal vein before and after stimulation with nutritional drink
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Determination of difference in baseline MR flow measurements and post prandial MR flow
大体时间: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)
2.5 years

次要结果测量

结果测量
措施说明
大体时间
Wich vessel or combination of vessels differentiate best
大体时间:2.5 years
Which vessel or which combination of vessels best differentiates between patients diagnosed with CGI and patients not diagnosed with CGI by MR flow measurement by computing sensitivity, specificity, predictive positive value and negative predictive value.
2.5 years
The severity of abdominal pain
大体时间:20/30/40 minutes
The severity of abdominal pain in course of time after stimulation with nutritional drink, using the Numeric Pain Intensity scale at baseline and 20, 30 and 40 minutes after nutritional drink
20/30/40 minutes
Determination of difference in MR flow measurements before and after treatment for CGI
大体时间:2.5 years
The difference in MR flow measurements of the mesenteric vessels prior to and after treatment in patients diagnosed with CGI with persistent relief of symptoms after treatment (in (mL/min/kg)
2.5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mohamed Ouhlous, md、Erasmus Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年8月1日

初级完成 (预期的)

2021年12月1日

研究完成 (预期的)

2021年12月1日

研究注册日期

首次提交

2016年7月12日

首先提交符合 QC 标准的

2016年8月17日

首次发布 (估计)

2016年8月23日

研究记录更新

最后更新发布 (实际的)

2021年3月9日

上次提交的符合 QC 标准的更新

2021年3月8日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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