Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia
NCT Number: NCT06468774
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Mesenteric Ischemia|Median Arcuate Ligament Syndrome
Sponsor: Oslo University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2037-05-31
Locations: Department of vascular surgery, Oslo University Hospital, Oslo, Norway

Summary:
Plasma Alpha glutathione S transferase (Alpha GST) has been previously demonstrated to be raised in patients with chronic mesenteric ischemia (CMI) caused by atherosclerosis and in patients with median arcuate ligament syndrome (MALS). The raised plasma level of Alpha GST has been demonstrated to decrease or normalize after surgical treatment of patients with CMI and MALS as compared with healthy individuals.

This study compares the plasma Alpha GST in patients with CMI and MALS with those with 1-Morbus Crohn, 2-Gallstone disease, and age-matched healthy individuals.

Besides, changes in the health-related quality of life (QoL) will be investigated in the study individuals.

Primary Outcome Measures: Plasma alpha Glutathione S transferase, This study compares the plasma Alpha GST in patients with CMI (n=30) and MALS (n=30) with those with 1-Morbus Crohn (n=30), 2-Gallstone disease (n=30), and age-matched healthy individuals (n=60).

After inclusion in the study, blood tests will be performed to exclude renal failure and liver disease.

Venous blood samples will be obtained before and 3 months after treatment in the patients with CMI and MALS. Blood samples will also be obtained from the individuals in the control groups twice ( at inclusion and 3 months apart ). The blood samples will be centrifuged and stored at -70 degrees until analyzed in batches with the ELISA technique.

The plasma levels of Alpha GST will be compared beside receiver operating characteristic curves (ROC), and the area under the curve(AUC) will be calculated., 3 years
Secondary Outcome Measures: Health related quality of life (QoL), Changes in the health-related quality of life (QoL) will be investigated in the study individuals. The EuroQol 5D (EQ5D) questionnaire, which is a generic tool, will be used to assess the QoL of the study patients. EQ5D is a generic tool for the assessment of health related quality of life and is translated to Norwegian language and validated tool for the assessmeent of changes in the health related quality of life. The patients will fill out the EQ5D at inclusion in the study and 1, 2, 5, and 10 years after treatment of CMI and MALS in the patient groups. EQ5D has 5 questions with 5 levels of answers to each question. It allows to a assess both physical and mental quality of health of the patients. It is translated into Norwegian and validated for QoL assessment., 5 years|Clinical outcomes of the treatment of CMI and MALS, Effect of treatment on the symptoms of CMI and MALS postoperatively at 30 and 90 days, and at 1, 2, 5 and 10 years. A study specific questionnaire has been deveolped to register the signs and symptoms of CMI and MALS. The patients in the study will fill-out the questionnaire before and after the treatment and will repeat it at every follow-up time-point. The patients in the study will be follow-up by the clinicians who are not directly involved with the study and therefore the clinical information obtained will be standarized and made independent of the clinician's background., 10 years|Cost utility analysis of the treatment of CMI and MALS, Quality adjusted life years (QALY ) estimation of the surgical and endovascular treatment of the patients with CMI and MALS. The costs of the treatment during the hospital stay will be calculated, compared with the costs of treatment given by the Norwegian Directorate of Health, QALY will be calculated based on the EQ5D results and the estimated treatment costs., 5 years|Intestinal ishemia biomarkers, Plasma levels of intestinal fatty acid binding protein (iFABP), plasma citruline, and immune modified albumin (IMA) before and after the treatment of CMI and MALS compared with the control groups. These are the biomarkers which have been demonstrated to be raised in plasma of the patients in CMI in previouus studies. Venous blood obtained fra the study individuals before and 3 months after the treatment of CMI and MALS will be analyzed with ELISA technique to discover any changes in these plasma biomarkers of ischemia. The groups will be compared for the changes in the plasma levels of thes biomarkers and tested for any association to intestinal ischemia., 5 years