Promoting Early Diagnosis of Chronic Mesenteric Ischemia

Chronic Mesenteric Ischemia Clinical Trial

— PROMISE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05735002
• Other study ID #: 9933
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2023
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 296
• Est. completion date: April 1, 2025
• Est. primary completion date: April 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Mesenteric Ischemia
• Ischemia
• Mesenteric Ischemia

Intervention

Diagnostic Test:
• 13C-butyrate breath test
breath test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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