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NCT Number: NCT05735002

Promoting Early Diagnosis of Chronic Mesenteric Ischemia

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.

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Key information

Conditions

Chronic Mesenteric Ischemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medisch Spectrum Twente, Enschede, Overijssel, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

13C-butyrate breath test

Diagnostic Test

breath test

Primary outcomes

Breath test

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Desirée Leemreis - van Noord, MD, PhD

CONTACT

[email protected]

Eva Karina Bocharewicz, MD, PhD Candidate

CONTACT

[email protected]

0031652216196

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

Maag Lever Darm Stichting

Registry information

Official study 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

Acronym: PROMISE

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Feb 21, 2023
Registry last updated: Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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