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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Mesenteric Ischemia
• Intervention / Treatment: Other: blood sampling

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diane Mège; Phone Number: +33 0491435817; Email: promotion.interne@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • Timone Hospital
    • Contact: Diane Mège, Dr; Phone Number: +33 0491435817; Email: promotion.interne@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Presenting acute myocardial ischemia, to avoid biasing the levels of the biomarkers studied (increased in this clinical situation)
• Patient in a period of exclusion from another research protocol at the time the non-opposition is signed,
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soluble adenosine deaminase assay for the diagnosis of IMA; 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; At the time of blood sampling for biological tests, 2 additional tubes of blood will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of lymphocyte adenosine deaminase and ischemia-modified albumin	To evaluate the discriminative abilities of lymphocyte adenosine deaminase and ischemia-modified albumin for the diagnosis of IMA in comparison with the reference method (injected abdominopelvic CT).	through study completion, an average of 2 years
threshold estimation for each biomarker	Determine the best threshold for each biomarker to diagnose patients with AMI.	through study completion, an average of 2 years
Estimate the discriminant performance associated with the threshold selected for each biomarker.	Estimate the discriminant performance associated with the threshold selected for each biomarker: sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, and their 95% confidence intervals	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.	Biological signature of IMA including lymphocyte adenosine deaminase, soluble adenosine deaminase, ischemia-modified albumin, lactates, amylase, CPK, LDH, ASAT, CRP and D dimers	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)	Compare the rates of each of the biomarkers tested as a function of AMI severity among patients with a CT-confirmed diagnosis of AMI.	through study completion, an average of 2 years
30-day prognosis	To compare the levels of each of the biomarkers tested in relation to the 30-day prognosis of AMI among patients with a CT-confirmed diagnosis of AMI.	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Peritoneal Diseases; Ischemia; Mesenteric Ischemia; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection; Phlebotomy
• Other Study ID Numbers: RCAPHM24_0416; 2024-A02484-43 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No