ClinicalTrials.gg
RecruitingNCT06869564SOS-ISMESUpdated Sep 23, 2026

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

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

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Acute Mesenteric Ischemia

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03

In context

Mesenteric Ischemia

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 →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Soluble adenosine deaminase assay for the diagnosis of IMA

    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

Interventions

  • Otherblood sampling

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

06

What researchers measure

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

  5. 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

  6. 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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Jan 2027, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2025
First posted
Mar 11, 2025
StartActual
Jun 29, 2025
Primary completionEst.
Jan 1, 2027
CompletionEst.
Feb 1, 2027
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06869564
Responsible party
Sponsor
First posted
Mar 11, 2025
Start date
Jun 29, 2025
Primary completion
Jan 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Diane Mège
Contact
promotion.interne@ap-hm.fr
0491435817 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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