Clinical trial NCT02875600: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemia
Oxygen Deficiency
Keywords: chronic gastro-intestinal ischemia
oxygen deficiency of the gastro-intestinal tract
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of difference in baseline MR flow measurements and post prandial MR flow
timeFrame: 2.5 years
Secondary outcomes:
measure: Wich vessel or combination of vessels differentiate best
timeFrame: 2.5 years
measure: The severity of abdominal pain
timeFrame: 20/30/40 minutes
measure: Determination of difference in MR flow measurements before and after treatment for CGI
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmusmc
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: Mohamed Ouhlous, md
role: PRINCIPAL_INVESTIGATOR
References: