Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06869564

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

Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-08-28

130

Participants Needed

1

Research Sites

83 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 18 years of age or older
  • Have severe abdominal pain with no clear diagnosis except suspected acute mesenteric ischemia
  • Scheduled for an injected abdominopelvic CT scan due to suspected AMI
  • Pregnant or breastfeeding women are eligible
  • Affiliated with the French social security system
  • Able to give written consent without objection
Not Eligible

You will not qualify if you...

  • Having acute myocardial ischemia at the time of the study
  • Currently excluded from another research protocol at consent
  • Legally protected persons deprived of liberty or socially vulnerable
  • Unable to read or understand French sufficiently to consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Timone hospital

Marseille, France, 13005

Actively Recruiting

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Research Team

D

Diane Mège

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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