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

Study acronym: SOS-ISMES
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Eligibility criteria expanded, about 9 words Secondary endpoints: details revised at 1 of 6 entries Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 6 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 1, 2026 to Jan 1, 2027 · Completion date: Jun 1, 2027 to Feb 1, 2027 · Start date changed from estimate of Jun 1, 2025 to Jun 29, 2025 · 1 morev4 Show 4 more changesShow less
    • Primary completion date: Dec 1, 2026 to Jan 1, 2027
    • Completion date: Jun 1, 2027 to Feb 1, 2027
    • Start date changed from estimate of Jun 1, 2025 to Jun 29, 2025
    • Site details revised
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Minor Study Identification, Study Status, Oversightv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06869564
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions Acute Mesenteric Ischemia
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov