IschemiaNCT02875600
Magnetic Resonance Flow Measurements of Mesenteric Arteries and Veins and Portal Vein
A study testing Nutri Drink in people with Ischemia and Oxygen Deficiency, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia, Oxygen Deficiency
- What is being tested?
- Nutri Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suspected of CGI referred to our hospital for further analysis
- Age ≥ 18 years
- Patients who gave informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Louisa Van Dijk, md contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmusmc
Rotterdam, South Holland, 3015CE
Laurens Groenendijk, 31 10 7033612, imaging.trialbureau@erasmusmc.nl
Mohamed Ouhlous, MD
About this study
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
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.
Read the 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.
- Conditions
- Ischemia, Oxygen Deficiency
- Being tested
- Nutri Drink
- Keywords
- chronic gastro-intestinal ischemia, oxygen deficiency of the gastro-intestinal tract
- Medical subject headings
- Ischemia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutri DrinkOther
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
| Study group | Role | What they receive |
|---|---|---|
| Nutri drink | Experimental | MRI flow measurements of mesenterial vessels and portal vein before and after stimulation with nutritional drink Receives: Other: Nutri Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2.5 years
Secondary outcomes (3)
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.
Measured: 2.5 years
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
Measured: 20/30/40 minutes
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)
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trialbureau radiology, Erasmus Medical Center
- Investigators
- Mohamed Ouhlous, md, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875600
- Sponsor's protocol ID
- MR flow
- Status last verified
- Mar 2021
- First submitted
- 12 Jul 2016
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02875600
- Acronym / sponsor ID
- MR flow
- Conditions
- Ischemia, Oxygen Deficiency
- Keywords
- chronic gastro-intestinal ischemia, oxygen deficiency of the gastro-intestinal tract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutri drink | Experimental | Other: Nutri DrinkMRI flow measurements of mesenterial vessels and portal vein before and after stimulation with nutritional drink |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suspected of CGI referred to our hospital for further analysis
- Age ≥ 18 years
- Patients who gave informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutri DrinkTo 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 | Other | Nutri drink |
Primary outcome
Determination of difference in baseline MR flow measurements and post prandial MR flow
Time frame: 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)
3 secondary outcomes
Wich vessel or combination of vessels differentiate best
Time frame: 2.5 years
The severity of abdominal pain
Time frame: 20/30/40 minutes
Determination of difference in MR flow measurements before and after treatment for CGI
Time frame: 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louisa Van Dijk, md contact
Mohamed Ouhlous, md principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutri Drink in people with Ischemia and Oxygen Deficiency, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurens Groenendijk (31 10 7033612, l.groenendijk@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of difference in baseline MR flow measurements and post prandial MR flow (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.