Acute Mesenteric IschemiaSOS-ISMESNCT06869564
Evaluation of the Discriminative Abilities of Biomarkers for the Diagnosis of Acute Mesenteric Ischemia Compared With Another Similar Clinical Presentation: a Pilot Study
A study testing blood sampling in people with Acute Mesenteric Ischemia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Mesenteric Ischemia
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2025to 1 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Timone hospital
Marseille, 13005
Diane Mège, Dr, 0491435817 ext. +33, promotion.interne@ap-hm.fr
About this 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.
Read more
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
- Acute Mesenteric Ischemia
- Being tested
- blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
At the time of blood sampling for biological tests, 2 additional tubes of blood will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Soluble adenosine deaminase assay for the diagnosis of IMA | Experimental | 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. Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 years
Secondary outcomes (6)
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).
Measured: through study completion, an average of 2 years
threshold estimation for each biomarker
Determine the best threshold for each biomarker to diagnose patients with AMI.
Measured: through study completion, an average of 2 years
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
Measured: through study completion, an average of 2 years
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
Measured: through study completion, an average of 2 years
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.
Measured: through study completion, an average of 2 years
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.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start29 Jun 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mesenteric IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869564
- Sponsor's protocol ID
- RCAPHM24_0416
- Other IDs
- 2024-A02484-43
- Acronym
- SOS-ISMES
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No