Clinical trial NCT06468774: Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia
Official title: Intestinal Ischemia Biomarker and Quality of Life of the Patients With Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Mesenteric Ischemia
Median Arcuate Ligament Syndrome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CMI and MALS patients with the vascular surgery department, Oslo University Hospital, with a consensus diagnosis of MALS and a diagnosis of CMI and schedules operative or endovascular treatment.

Control groups are the individuals under treatment with the Oslo University Hospital or regular blood donors at the hospital.

Brief 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.

Detailed description: Patients with CMI and MALS usually complain of postprandial abdominal pain, changes in food intake patterns, and weight loss. These symptoms are often shared with many other more common diseases. Therefore, the diagnosis of CMI, and especially MALS, is often an exclusion diagnosis. To this date, no biomarker of intestinal ischemia with sufficient sensitivity and specificity has been identified for routine clinical use.

In our previous study, we found raised levels of plasma Alpha glutathione S transferase (Alpha GST) (7.8 ng/mL) in patients with CMI caused by atherosclerosis and in patients with MALS (8.4 ng/mL). 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 (3.3 ng/mL).

However, the previous study was not appropriately powered and did not include a control group with similar clinical symptoms as in the patients with CMI and MALS.

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).

The CMI and MALS patients diagnosed with CTA and duplex ultrasound and scheduled to have either endovascular (PTA or stent) or open surgery ( mesenteric bypass ) treatment will be included in this study.

Duplex ultrasound will be used to exclude CMI and MALS in the individuals in the control groups. 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.

In addition to Alpha GST, the plasma of the study individuals will also be tested for other potential markers of intestinal ischemia, intestinal fatty acid binding protein (i-FABP), citrulline, and ischemia-modified albumin (IMA).

The study will also follow the patients participating in the study for clinical changes in symptoms. In addition, patient demographics, comorbidities, treatment demographics, and complications will be registered. A questionnaire has been constructed for the patient groups in the study to register the clinical signs and symptoms. The patients will fill out the questionnaire before and after the treatment. The study patients will be followed up after treatment at the outpatient clinic at 1 and 3 months and at 1, 2, 5, and 10 years. Duplex ultrasound will be performed at all follow-up time points. Participants in the control groups will be examined with duplex ultrasound twice after inclusion in the study, three months apart.

Besides, changes in the health-related quality of life (QoL) will be investigated in the study individuals. The EuroQol 5D (EQ5D) questionnaire will be used to assess the QoL of the study patients. 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.

Information from the quality of life and the costs of treatment during the hospital stay will be used to estimate the quality-adjusted life years and the cost-utility of treating patients with CMI and MALS.

Eligibility criteria: Inclusion Criteria: Above 18 years and has given informed written consent for treatment and study participation

For the patient groups :

Group 1: Has CTA or ultrasound diagnosed MALS and is scheduled operative treatment.

Group 2: Has CTA or ultrasound diagnosed CMI and is scheduled operative or endovascular treatment.

For the control group:

Group 3- Has ultrasound based diagnosis of cholelithiasis and is scheduled for cholecystectomy.

Group 4- Has established Mb Crohn diagnosis and under gastric lab follow-up. Group 5- Young healthy blood donors of mean age 45 years and has excluded MALS or CMi with ultrasound.

Group 6- Healthy blood donors of mean age 70 years and has excluded MALS or CMi with ultrasound.

Exclusion Criteria: Age less than 18 years Has nor given written consent.

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Primary outcomes:
measure: Plasma alpha Glutathione S transferase
timeFrame: 3 years
Secondary outcomes:
measure: Health related quality of life (QoL)
timeFrame: 5 years
measure: Clinical outcomes of the treatment of CMI and MALS
timeFrame: 10 years
measure: Cost utility analysis of the treatment of CMI and MALS
timeFrame: 5 years
measure: Intestinal ishemia biomarkers
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of vascular surgery, Oslo University Hospital
Study officials:
affiliation: Department of vascular surgery, Oslo University Hospital
name: Syed Sajid Hussain Kazmi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kazmi SSH, Safi N, Berge ST, Kazmi M, Sundhagen JO, Julien K, Thorsby PM, Anonsen KV, Medhus AW, Hisdal J. Plasma alpha-Glutathione S-Transferase in Patients with Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome. Vasc Health Risk Manag. 2022 Jul 21;18:567-574. doi: 10.2147/VHRM.S365625. eCollection 2022.