Helping find chronic mesenteric ischemia earlier
PRomoting Early Diagnosis Of Chronic Mesenteric ISchEmia by a Mesenteric Artery Calcium Score Based Risk Stratification and Detection of Postprandial Mucosal Ischemia by Butyrate Breath Testing
This project tests whether a 13C-butyrate breath test combined with CT-based mesenteric artery calcium scoring can help diagnose adults with suspected chronic mesenteric ischemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 296 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 4 sites (Enschede, Overijssel and 3 other locations) |
| Trial ID | NCT05735002 on ClinicalTrials.gov |
What this trial studies
This is an observational, multi-center effort enrolling adults referred for possible chronic mesenteric ischemia. Participants undergo a noninvasive 13C-butyrate breath test to detect meal-related mucosal ischemia and have their CT scans analyzed for mesenteric arterial calcification similar to coronary calcium scoring. The aim is to identify a sensitive rule-out test and a specific confirmation test to reduce reliance on lengthy, invasive diagnostic workups. Key exclusions include prior mesenteric revascularization, unavailable or contraindicated CT imaging, common celiac–SMA origin, delayed gastric emptying, and untreated small intestinal bacterial overgrowth.
Who should consider this trial
Good fit: Adults (18 and older) referred to participating centers with clinical suspicion of chronic mesenteric ischemia who can give informed consent and have available CT imaging are ideal candidates.
Not a fit: Patients with prior mesenteric artery revascularization, no available CT or contraindications to CT, common celiac/SMA origin, pregnancy, known delayed gastric emptying, or untreated small intestinal bacterial overgrowth are unlikely to benefit from these tests.
Why it matters
Potential benefit: If successful, these methods could offer quicker, less invasive ways to rule out or confirm chronic mesenteric ischemia and reduce the need for complicated diagnostic procedures.
How similar studies have performed: Quantifying mesenteric arterial calcification borrows from the well-established coronary calcium score approach, but applying a 13C-butyrate breath test to detect postprandial mucosal ischemia is a novel application with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a clinical suspicion of CMI referred to Maagdarm Ischemie Centrum Rotterdam (MICR), MST or UMCG. * Patients ≥ 18 years Exclusion Criteria: * Patients who are unable to give informed consent * Patients with previous mesenteric artery revascularization * No available CT imaging and contraindications for CT imaging (e.g. pregnancy) * Common origin of the celiac artery and superior mesenteric artery * Known delayed gastric emptying * Known and untreated small intestinal bacterial overgrowth
Where this trial is running
Enschede, Overijssel and 3 other locations
- Medisch Spectrum Twente — Enschede, Overijssel, Netherlands (Not_yet_recruiting)
- University Medical Centre Groningen — Groningen, Provincie Groningen, Netherlands (Not_yet_recruiting)
- Erasmus University Medical Centre Rotterdam — Rotterdam, South Holland, Netherlands (Recruiting)
- Franciscus — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Eva Karina Bocharewicz, MD, PhD Candidate
- Email: e.bocharewicz@erasmusmc.nl
- Phone: 0031652216196
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.