Mesenteric Ischemia Markers Study
ConditionMesenteric Vascular Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBelarusian State Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Consent declined by patient or relatives
Failure to meet inclusion criteria
Trial design
Design model
Single group
Treatments tested in this trial
Blood samples
Diagnostic testBlood samples as diagnostic tests are the only intervention in the trial
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: MA data and blood samples dataOther 1 intervention
Trial outcomes
Primary outcomes
1
Increasing in the level of mesenteric ischemia (MI) markers above the reference threshold level within 1 day after enrollment in the study
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).
Time frame
From enrollment to the 24 hoursSponsors and contacts
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Source ClinicalTrials.gov