Promoting Early Diagnosis of Chronic Mesenteric Ischemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2027-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chronic Mesenteric Ischemia Breath Testing

NCT06022588

Chronic Mesenteric Ischemia

COMPLETED NA

Diet and Disease Activity in Patients With Inflammatory Bowel Disease

NCT01756963

Inflammatory Bowel Disease

COMPLETED

Characterization of Disease Related Changes in Inflammatory Bowel Disease Using Fecal Metabolite Profiling

NCT01666717

Inflammatory Bowel Diseases

COMPLETED

Evaluation of a New Oral Contrast Agent for MR Enterography in the Assessment of Crohn Disease in the Small Bowel

NCT00587210

Crohn Disease

COMPLETED

Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease

NCT06770140

Crohn's Disease (CD)

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Mesenteric Ischemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with suspected CMI

13C-butyrate breath test

Intervention Type DIAGNOSTIC_TEST

breath test

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

13C-butyrate breath test

breath test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No