Promoting Early Diagnosis of Chronic Mesenteric Ischemia (PROMISE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Mesenteric Ischemia
• Intervention / Treatment: Diagnostic test: 13C-butyrate breath test

• Study Type: Observational
• Enrollment (Estimated): 296

Contacts and Locations

• Study Contact: Name: Eva Karina Bocharewicz, MD, PhD Candidate; Phone Number: 0031652216196; Email: e.bocharewicz@erasmusmc.nl
• Study Contact Backup: Name: Desirée Leemreis - van Noord, MD, PhD; Email: d.leemreis-vannoord@erasmusmc.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Not yet recruiting
    • University Medical Centre Groningen
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7512KZ
      • Not yet recruiting
      • Medisch Spectrum Twente
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3045PM
      • Recruiting
      • Franciscus
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus University Medical Centre Rotterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients with suspected CMI

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with suspected CMI	Diagnostic test: 13C-butyrate breath test; breath test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2023-2025
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.	2023-2035

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Maag Lever Darm Stichting

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: breath test, chronic mesenteric ischemie, calcium scoring
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Peritoneal Diseases; Ischemia; Chronic Disease; Mesenteric Ischemia
• Other Study ID Numbers: 9933 (Other Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No