Evaluation of the Discriminative Abilities of Biomarkers for the Diagnosis of Acute Mesenteric Ischemia Compared With Another Similar Clinical Presentation: a Pilot Study

NCT06869564 | Recruiting

• 2 other identifiers: RCAPHM24_04162024-A02484-43
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Acute mesenteric ischemia (AMI) is associated with high mortality (50-80%). The prognosis depends on the time it takes to diagnose the condition, and the possibility of revascularization in eligible patients. Delayed diagnosis is due in particular to the aspecific clinical presentation and the absence of biomarkers to guide early diagnosis, lactates often being elevated at an already irreversible stage. Adenosine deaminase is produced in the presence of ischemia (known from myocardial ischemia), and is present on the surface of intestinal villi. The investigator's hypothesis is that, in the event of digestive ischemia resulting in abnormalities of mesenteric permeability, adenosine deaminase will enter the bloodstream and increase its soluble plasma activity, along with an increase in lymphocyte-bound adenosine deaminase. The main objective is to evaluate the discriminatory capacities of soluble adenosine deaminase, collected via blood sampling, for the diagnosis of IMA in comparison with the reference method (injected abdominopelvic CT scan), performed for abdominal pain suggestive of IMA. The study will be based on a prospective monocentric cohort. Currently, there is no specific biological marker for IMA, and the gold standard for diagnosis is the injected abdominopelvic CT scan, performed for hyperintense abdominal pain. Two groups will be identified on the basis of the gold-standard abdominopelvic scan:

• the "IMA patients" group: patients with hyperintense abdominal pain, and IMA confirmed by CT scan
• the "non-IMA patients" group: patients with hyperintense abdominal pain, but with a diagnosis other than IMA on the CT scan. 130 subjects will be included in this study Inclusion period: 18 months Follow-up period: 1 month Analysis period: 5 months Total duration: 24 months

Conditions

Acute Mesenteric Ischemia

Outcome Measures

Primary Outcomes (1)

• Identify soluble adenosine deaminase as a marker for the diagnosis of IMA

  In comparison with the reference method (injected abdominopelvic CT scan), identification of soluble adenosine deaminase as a marker for the diagnosis of IMA.

  through study completion, an average of 2 years

Secondary Outcomes (6)

• Rate of lymphocyte adenosine deaminase and ischemia-modified albumin

  through study completion, an average of 2 years

• threshold estimation for each biomarker

  through study completion, an average of 2 years

• Estimate the discriminant performance associated with the threshold selected for each biomarker.

  through study completion, an average of 2 years

• Description of a biological signature for IMA, including the different biomarkers measured specifically and those usually measured.

  through study completion, an average of 2 years

• Measurement of the extent of digestive resection leaving in place the equivalent of a short small bowel (<1.5m after the duodenum)

  through study completion, an average of 2 years

Study Arms (1)

Soluble adenosine deaminase assay for the diagnosis of IMA

EXPERIMENTAL

Assess the overall discriminatory performance of soluble adenosine deaminase in the diagnosis of IMA, compared with the reference method (injected abdominopelvic CT scan). The area under the ROC curve will be estimated, together with its 95% confidence interval.

Other: blood sampling

Interventions

blood sampling OTHER

At the time of blood sampling for biological tests, 2 additional tubes of blood will be taken.

Soluble adenosine deaminase assay for the diagnosis of IMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older
• with an indication (hyperintense abdominal pain with no obvious diagnosis other than acute mesenteric ischemia) for an injected abdominopelvic scan for hyperintense abdominal pain suspected of acute mesenteric ischemia
• Including pregnant or breast-feeding women, as this is a risk factor for AMI in young subjects
• Affiliated with the French social security system
• Able to express non-opposition in writing

You may not qualify if:

• Presenting acute myocardial ischemia, to avoid biasing the levels of the biomarkers studied (increased in this clinical situation)
• Person protected by articles L1121-6 and L1121-8 of the French Public Health Code (deprived of liberty by court order, socially vulnerable, adult incapable or unable to express non-opposition).
• Persons who are unable to read and understand the French language sufficiently to give their consent to participate in research.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Timone hospital

Marseille, 13005, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Diane Mège

CONTACT

0491435817; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 11, 2025
• Study Start: June 29, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-07

Locations

FR (1)