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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • blood sampling

    Other intervention

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

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: Soluble adenosine deaminase assay for the diagnosis of IMAExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
through study completion, an average of 2 years

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.