Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia

Chronic Mesenteric Ischemia Clinical Trial

Official title:

Intestinal Ischemia Biomarker and Quality of Life of the Patients With Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06468774
• Other study ID #: 607155
• Status: Recruiting
• Start date: June 10, 2024
• Est. completion date: May 31, 2037

Study information

• Verified date: June 2024
• Source: Oslo University Hospital
• Contact: Syed Sajid Hussain Kazmi, MD, PhD
• Phone: 4792468309
• Email: sshkazmi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 31, 2037
• Est. primary completion date: May 31, 2037
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Chronic Disease
• Chronic Mesenteric Ischemia
• Ischemia
• Mesenteric Ischemia
• Syndrome

Locations

Country	Name	City	State
Norway	Department of vascular surgery, Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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