Mesenteric Ischemia Markers Study In The Presence Of Mesenteric Arteries Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Increasing in the level of mesenteric ischemia (MI) markers above the reference threshold level within 1 day after enrollment in the study
研究概览
简要总结
Vascular bowel disease remains a socially significant and potentially fatal condition (if it develops into AMI), primarily due to delayed diagnosis. Blood biomarkers are theoretically ideal for early risk stratification (like troponins in myocardial infarction). However, the existing evidence base is characterized by low quality and high heterogeneity, which hinders their use in clinical practice. Therefore, there is an urgent and unmet clinical need for high-quality, methodologically rigorous research to validate biomarkers in MI. A current study (MESMARK) is to be undertaken to identify combinations of biomarkers that can reliably identify mesenteric ischemia (MI) and distinguish between non-transmural and transmural clinical relevant ischemia.
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
- 是
入选标准
- •18 years or older, all sex
- •Initial decision, the presence of angio-visualisation of the MA and suspicion of mesenteric arteries diseases
- •Patient's consent to participate in the study
- •No pregnancy, no history of major operations on MA, the gastrointestinal tract and digestive organs (except appendectomy, endoscopic polypectomy).
排除标准
- •Consent declined by patient or relatives
- •Failure to meet inclusion criteria
研究组 & 干预措施
MA data and blood samples data
Patients with MA lesions and suspicion of acute or chronic vascular diseases of the intestine. Patients with suspicion of AMI or CMI are to be included and blood samples are to be collected. Blood samples is the only intervention.
干预措施: Blood samples (Diagnostic Test)
结局指标
主要结局
Increasing in the level of mesenteric ischemia (MI) markers above the reference threshold level within 1 day after enrollment in the study
时间窗: From enrollment to the 24 hours
Assessment of serum markers level is intended to identify reliable serum markers or the panel of them as biomarkers for the diagnosis of MI. The endpoint is "increasing in serum marker level above the threshold reference level within 24 hours of objectively suspected MI or not". Markers with elevated above the reference threshold level will be assessed individually and in combination (as a marker panel) later to calculate their sensitivity and specificity in diagnostic of MI. These markers include intestinal fatty acid-binding protein (I-FABP), alpha-glutathione S-transferase (α-GST), ischaemia-modified albumin (IMA), D-lactate, D-dimer, adropin, hypoxia-inducible factor (HIF-1α).
次要结局
未报告次要终点
研究者
Hleb But-Husaim
Associate Professor of the Department of Surgery and Endoscopy BSMU, MD, PhD
Belarusian State Medical University