Clinical trial NCT06869564: Evaluation of the Discriminative Abilities of Biomarkers for the Diagnosis of Acute Mesenteric Ischemia Compared With Another Similar Clinical Presentation: a Pilot Study
Official title: Evaluation of the Discriminative Abilities of Biomarkers for the Diagnosis of Acute Mesenteric Ischemia Compared With Another Similar Clinical Presentation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Mesenteric Ischemia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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.

Primary outcomes:
measure: Identify soluble adenosine deaminase as a marker for the diagnosis of IMA
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Rate of lymphocyte adenosine deaminase and ischemia-modified albumin
timeFrame: through study completion, an average of 2 years
measure: threshold estimation for each biomarker
timeFrame: through study completion, an average of 2 years
measure: Estimate the discriminant performance associated with the threshold selected for each biomarker.
timeFrame: through study completion, an average of 2 years
measure: Description of a biological signature for IMA, including the different biomarkers measured specifically and those usually measured.
timeFrame: through study completion, an average of 2 years
measure: Measurement of the extent of digestive resection leaving in place the equivalent of a short small bowel (<1.5m after the duodenum)
timeFrame: through study completion, an average of 2 years
measure: 30-day prognosis
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Timone hospital
Study officials:
References: