Magnetic Resonance Flow Measurements of Mesenteric Arteries and Veins and Portal Vein
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 9, 2021
March 1, 2021
5.3 years
July 12, 2016
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
2.5 years
Secondary Outcomes (3)
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
Study Arms (1)
Nutri drink
EXPERIMENTALMRI flow measurements of mesenterial vessels and portal vein before and after stimulation with nutritional drink
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients suspected of CGI referred to our hospital for further analysis
- Age ≥ 18 years
- Patients who gave informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasmusmc
Rotterdam, South Holland, 3015CE, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed Ouhlous, md
Erasmus Medical Center
Central Study Contacts
Louisa Van Dijk, md
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr
Study Record Dates
First Submitted
July 12, 2016
First Posted
August 23, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
March 9, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share