Promoting Early Diagnosis of Chronic Mesenteric Ischemia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a clinical suspicion of CMI referred to Maagdarm Ischemie Centrum Rotterdam (MICR), MST or UMCG.

Patients ≥ 18 years

Disqualifiers

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

Trial population

All patients with suspected CMI

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 13C-butyrate breath test

    Diagnostic test

    breath test

Treatment groups

296 Participants
are divided into 1 treatment group
Group A: Patients with suspected CMI1 intervention

Trial outcomes

Primary outcomes

1

Breath test

\- 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.

Time frame
2023-2025
2

calcium scores

To 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.

Time frame
2023-2035

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

Maag Lever Darm Stichting

Collaborator