Skip to content

Promoting Early Diagnosis of Chronic Mesenteric Ischemia

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05735002
Acronym
PROMISE
Enrollment
296
Registered
2023-02-21
Start date
2024-02-01
Completion date
2027-04-01
Last updated
2025-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Mesenteric Ischemia

Keywords

breath test, chronic mesenteric ischemie, calcium scoring

Brief summary

CMI is an incapacitating disease and timely diagnosis remains problematic. Despite the substantial compensatory capacity of the mesenteric circulation CMI is relatively common, its incidence being comparable to other well-known diseases like Crohn's disease. Diagnostic tools are needed for two purposes since the exclusion of CMI currently requires a cumbersome complication-prone diagnostic workup and since a definitive diagnosis is mainly established per exclusionem. First, a sensitive test is desirable to rule out CMI and avoid excessive diagnostic investigations. Quantification of mesenteric arterial calcification on computed tomography (CT) seems suitable for this purpose, synonymous with the coronary artery calcium score. Second, a specific test is required confirming CMI by detection of mucosal ischemia during a meal, when oxygen demand peaks. A breath test, based on the requirement of oxygen to absorb and metabolize 13C-butyrate in the enterocyte, could detect mucosal ischemia Objective: Facilitating diagnosis of chronic mesenteric ischemia (CMI) using 1) the mesenteric artery calcium score (MACS) and 2) mucosal ischemia detection by butyrate breath testing Study design: Multicentre prospective cohort studies.

Interventions

DIAGNOSTIC_TEST13C-butyrate breath test

breath test

Sponsors

Maag Lever Darm Stichting
CollaboratorOTHER
Erasmus Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Breath test2023-2025\- To validate the butyrate breath test as a specific functional test with a high positive predictive value to rightfully diagnose and select patients who will benefit from invasive treatment.
calcium scores2023-2035To validate the mesenteric artery calcium score as a readily available, easy, and sensitive test with a high negative predictive value to either rule out CMI or select patients for further investigations.

Countries

Netherlands

Contacts

Primary ContactEva Karina Bocharewicz, MD, PhD Candidate
e.bocharewicz@erasmusmc.nl0031652216196
Backup ContactDesirée Leemreis - van Noord, MD, PhD
d.leemreis-vannoord@erasmusmc.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026