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NCT Number: NCT06869564

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Timone hospital

Marseille, 13005, France

Location status: Recruiting

Location contact

Diane Mège, Dr

CONTACT

[email protected]

0491435817 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Other

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

Primary outcomes

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

    Time frame: through study completion, an average of 2 years

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

Secondary outcomes

  1. Rate of lymphocyte adenosine deaminase and ischemia-modified albumin

    Time frame: through study completion, an average of 2 years

    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).

  2. threshold estimation for each biomarker

    Time frame: through study completion, an average of 2 years

    Determine the best threshold for each biomarker to diagnose patients with AMI.

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

    Time frame: through study completion, an average of 2 years

    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

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

    Time frame: through study completion, an average of 2 years

    Biological signature of IMA including lymphocyte adenosine deaminase, soluble adenosine deaminase, ischemia-modified albumin, lactates, amylase, CPK, LDH, ASAT, CRP and D dimers

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

    Time frame: through study completion, an average of 2 years

    Compare the rates of each of the biomarkers tested as a function of AMI severity among patients with a CT-confirmed diagnosis of AMI.

  6. 30-day prognosis

    Time frame: through study completion, an average of 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Mège

CONTACT

[email protected]

0491435817 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: SOS-ISMES

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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