PROMISE: Promoting Early Diagnosis of Chronic Mesenteric Ischemia

Erasmus Medical Center (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 13C-butyrate breath test

Study Design

Study Type:
Anticipated Enrollment :
296 participants
Observational Model:
Time Perspective:
Official Title:
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
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 2, 2023
Anticipated Study Completion Date :
Apr 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Erasmus Medical Center


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Marco J. Bruno, Gastroenterologist, Erasmus Medical Center Identifier:
Other Study ID Numbers:
  • 9933
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Marco J. Bruno, Gastroenterologist, Erasmus Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023