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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02484-43 | Other Identifier | IDRCB |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling | Other | At the time of blood sampling for biological tests, 2 additional tubes of blood will be taken. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diane Mège | Contact | 0491435817 | +33 | promotion.interne@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Timone hospital | Recruiting | Marseille | 13005 | France |
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| threshold estimation for each biomarker |
Determine the best threshold for each biomarker to diagnose patients with AMI. |
| 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 | 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 | 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. | 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. | through study completion, an average of 2 years |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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