Blood Flow and Oxygenation in the Portal Vein in Subjects With Chronic Narrowing of the Blood Vessels to the Gut

NCT07182669 | Not Yet Recruiting

• 1 other identifier: VEK H-25043058
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will, with an Magnetic Resonance Imaging (MRI) method, measure the oxygen content in the portal vein, which conduct the blood from the guts to the liver. Examinations will be performed on 20 subjects with meal related abdominal pain due to severe narrowing of the vessels conduction blood to the guts,compared to 20 subjects with similar narrowing of the abdominal vessels, but without meal related pain. The goal of the study is to test a non-invasive, radiation free method to diagnose patients with abdominal pain due to compromized blood supply (chronic mesenteric ischemia).

Conditions

Chronic Mesenteric Ischemia

Keywords

chronic mesenteric ischemia; fMRI; MRI-TRUST; Portal oxygen concentration

Outcome Measures

Primary Outcomes (1)

• flow and oxygen concentration in the portal vein

  Fasting and postprandial flow and oxygen concentration in the portal vein, measured by MRI

  From enrollment Through study completion, an average of 2 years

Study Arms (2)

20 subjects with mesenteric ischemia

Intake of a meal during the MRI-scan

20 subjects with stenosis of mesnteric arteries, but no postprandial pain

Intake of a meal during the MRI-scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruited from the participating hospital (Copenhagen University Hospital, Rigshospitalet and Copenhagen University Hospital, Hvidovre Hospital)

You may qualify if:

• \- Written informed consent
• Male or female persons \> 18 years
• Subjects with postprandial abdominal pain considered compatible with mesenteric ischemia, and severe stenosis of the SMA and eventually other mesenteric arteries, diagnosed with CT-angiography or Doppler ultrasound
• OR subjects with severe stenosis of the SMA and eventually other mesenteric arteries, diagnosed with CT-angiography or Doppler ultrasound, but not postprandial pain

You may not qualify if:

• \- Serious concurrent illness
• BMI \> 30
• Cardiac arrhythmia
• Anemia with Hgb \< 7,0 mmol/l
• Pregnancy or breastfeeding (urine HCG is performed on all fertile women)
• Systolic blood pressure \< 90 or \> 200 mmHg
• Claustrophobia
• Patients who, in the judgement of the investigator, is incapable of participating
• Metallic foreign objects in the body, or pacemakers

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Dept. of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Rigshospitalet

Copenhagen, State, 2100 Ø, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples analyzed for GIP and GLP-1

Study Officials

• Ulrik B Andersen, MD, Consultant

  Dept. of Clinical Physiology and Nuclear Medicine, Rigshospitalet, Glostrup

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrik B. Andersen, MD

CONTACT

+4528944529; ulba@regionh.dk

Bryan Haddock, Leading physician

CONTACT

+4520646534; bryan.haddock@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, Consultant

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: Forwarded by reasonably motivated request

Locations

DK (1)