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Recruiting NCT06869564

NCT06869564 Evaluation of the Discriminative Abilities of Biomarkers for the Diagnosis of Acute Mesenteric Ischemia Compared With Another Similar Clinical Presentation: a Pilot Study

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Clinical Trial Summary
NCT ID NCT06869564
Status Recruiting
Phase
Sponsor Assistance Publique Hopitaux De Marseille
Condition Acute Mesenteric Ischemia
Study Type INTERVENTIONAL
Enrollment 130 participants
Start Date 2025-06-29
Primary Completion 2027-01-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
blood sampling

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 130 participants in total. It began in 2025-06-29 with a primary completion date of 2027-01-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Diane Mège

✉ promotion.interne@ap-hm.fr

📞 0491435817

Frequently Asked Questions

Who can join the NCT06869564 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Mesenteric Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06869564 currently recruiting?

Yes, NCT06869564 is actively recruiting participants. Contact the research team at promotion.interne@ap-hm.fr for enrollment information.

Where is the NCT06869564 trial being conducted?

This trial is being conducted at Marseille, France.

Who is sponsoring the NCT06869564 clinical trial?

NCT06869564 is sponsored by Assistance Publique Hopitaux De Marseille. The trial plans to enroll 130 participants.

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