An interventional study of blood sampling in Acute Mesenteric Ischemia, sponsored by Assistance Publique Hopitaux De Marseille. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic
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 "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
40 studies on the registry are indexed under Mesenteric Ischemia; 14 are open to participants now.
This study's planned enrollment of 130 is above the median of 110 across 14 interventional studies indexed under Mesenteric Ischemia.
Browse Mesenteric Ischemia studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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Exclusion Criteria:
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.
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.
Time frame: through study completion, an average of 2 years
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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 2 years
Started Jun 2025 (actual). Primary completion is estimated for Jan 2027, 18 months after the start.
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