Promoting Early Diagnosis of Chronic Mesenteric Ischemia

Not yet recruiting

• Conditions: Chronic Mesenteric Ischemia

• Registration Number: NCT05735002
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Study Start: 2023-04-01
• Primary Completion: 2023-04-02
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

• Patients with a clinical suspicion of CMI referred to to Maagdarm Ischemie Centrum Rotterdam (MICR).
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breath test	2023-2025	- 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 scores	2023-2035	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.