Evaluation of the Discriminative Abilities of Biomarkers for the Diagnosis of Acute Mesenteric Ischemia Compared With Another Similar Clinical Presentation: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Identify soluble adenosine deaminase as a marker for the diagnosis of IMA
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: blood sampling (Other)
结局指标
主要结局
Identify soluble adenosine deaminase as a marker for the diagnosis of IMA
时间窗: through study completion, an average of 2 years
In comparison with the reference method (injected abdominopelvic CT scan), identification of soluble adenosine deaminase as a marker for the diagnosis of IMA.
次要结局
- Rate of lymphocyte adenosine deaminase and ischemia-modified albumin(through study completion, an average of 2 years)
- threshold estimation for each biomarker(through study completion, an average of 2 years)
- Estimate the discriminant performance associated with the threshold selected for each biomarker.(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.(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)(through study completion, an average of 2 years)
- 30-day prognosis(through study completion, an average of 2 years)