RecruitingNCT05735002

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


Sponsor

Erasmus Medical Center

Enrollment

296 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Patients with a clinical suspicion of CMI referred to Maagdarm Ischemie Centrum Rotterdam (MICR), MST or UMCG.
  • Patients ≥ 18 years

Exclusion Criteria6

  • 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

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Interventions

DIAGNOSTIC_TEST13C-butyrate breath test

breath test


Locations(4)

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Erasmus University Medical Centre Rotterdam

Rotterdam, South Holland, Netherlands

Franciscus

Rotterdam, South Holland, Netherlands

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NCT05735002


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