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

Primary Purpose

Ischemia, Oxygen Deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Nutri Drink
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemia focused on measuring chronic gastro-intestinal ischemia, oxygen deficiency of the gastro-intestinal tract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ErasmusmcRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutri drink

Arm Description

MRI flow measurements of mesenterial vessels and portal vein before and after stimulation with nutritional drink

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Wich vessel or combination of vessels differentiate best
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.
The severity of abdominal pain
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
Determination of difference in MR flow measurements before and after treatment for CGI
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)

Full Information

First Posted
July 12, 2016
Last Updated
March 8, 2021
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02875600
Brief Title
Magnetic Resonance Flow Measurements of Mesenteric Arteries and Veins and Portal Vein
Official Title
Magnetic Resonance Flow Measurements of Mesenteric Arteries and Veins and Portal Vein With Food Stimulation in Patients Suspected of Chronic Gastro-intestinal Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Oxygen Deficiency
Keywords
chronic gastro-intestinal ischemia, oxygen deficiency of the gastro-intestinal tract

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutri drink
Arm Type
Experimental
Arm Description
MRI flow measurements of mesenterial vessels and portal vein before and after stimulation with nutritional drink
Intervention Type
Other
Intervention Name(s)
Nutri Drink
Intervention Description
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
Primary Outcome Measure Information:
Title
Determination of difference in baseline MR flow measurements and post prandial MR flow
Description
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)
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Wich vessel or combination of vessels differentiate best
Description
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.
Time Frame
2.5 years
Title
The severity of abdominal pain
Description
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
Time Frame
20/30/40 minutes
Title
Determination of difference in MR flow measurements before and after treatment for CGI
Description
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)
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suspected of CGI referred to our hospital for further analysis Age ≥ 18 years Patients who gave informed consent Exclusion Criteria: Age < 18 years Unable to give informed consent Pregnancy 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurens Groenendijk
Phone
31 10 7033612
Email
l.groenendijk@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Louisa Van Dijk, md
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Ouhlous, md
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmusmc
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3015CE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurens Groenendijk
Phone
31 10 7033612
Email
imaging.trialbureau@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Mohamed Ouhlous, MD
First Name & Middle Initial & Last Name & Degree
Louisa van DIjk, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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