Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia

NCT ID: NCT06468774

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2037-05-31

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). 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 pattern, 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 a previous study, raised levels of plasma Alpha glutathione S transferase (Alpha GST) (7.8 ng/mL) in patients with CMI caused by atherosclerosis and in the patients with MALS (8.4 ng/mL). The raised plasma level of Alpha GST has been demonstrated to decrease or normalize after surgical improvement of the intestinal circulation in patients with CMI and MALS as compared with healthy individuals (3.3 ng/mL). However, the 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 will compare the plasma Alpha GST levels in patients with CMI (n=30) and MALS (n=30) 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, venous blood samples will be taken to exclude renal failure and liver disease. The blood samples will be repeated within 3 months. The blood samples will be centrifuged and stored at -70 degrees until analyzed in batches with the ELISA technique. Participants in the control groups will be examined with duplex ultrasound at the time of inclusion in the study and agian at three months.

In the patient groups, i.e., CMI and MALS, the venous blood samples will be obtained before and 3 months after the treatment. 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, i.e., 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 of the treatment 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.

Furthermore, 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. EQ-5D can be converted to a single summary index by applying a formula that attaches weight to each of the levels in each dimension. The EQ-5D index is varying between 0 to 1 where 1 presents best health condition and 0 presenting the worst health state .

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 (QALY) and the cost-utility of treating patients with CMI and MALS.

Conditions

Chronic Mesenteric Ischemia; Median Arcuate Ligament Syndrome; Crohn Disease; Cholelithiasis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Median arcuate ligament syndrome (MALS)

Patients with MALS Scheduled for laparoskopic decompression.

Laparoscopic surgery

Intervention Type: PROCEDURE

The patients in the MALS group will be treated through transperitoneal ventral approach for the laparoscopic release of the celiac artery. Median arcuate ligament and any muscle or nerve tissue crossing the cranial surface of the celiac artery will be divided to release the celiac artery from compression.

In the patients with CMI open antegrade or retrograde bypass to celiac artery or superior mesenteric artery or both will be performed.

For operative treatment will be performed in general anaethesia whereas the endovacular treatment with PTA with stent for CMI will be performed in local anaethesia.

Chronic mesenteric ischemia (CMI)

Patients with CMI caused by atherosclerotic stenosis or occlusion of celiac artery, superior mesenteric artery ( one or both arteries ), and scheduled treatment with either PTA/stent or mesenteric bypass.

Laparoscopic surgery

Intervention Type: PROCEDURE

The patients in the MALS group will be treated through transperitoneal ventral approach for the laparoscopic release of the celiac artery. Median arcuate ligament and any muscle or nerve tissue crossing the cranial surface of the celiac artery will be divided to release the celiac artery from compression.

In the patients with CMI open antegrade or retrograde bypass to celiac artery or superior mesenteric artery or both will be performed.

For operative treatment will be performed in general anaethesia whereas the endovacular treatment with PTA with stent for CMI will be performed in local anaethesia.

Morbus Crohn intestine

Patients with diagnosed Mb Crohn of intestine who does not have CMI or MALS excluded with duplex ultrasound.

No interventions assigned to this group

Cholilithiasis

Patients with diagnosed Cholilithiasis who is scheduled for operative chelecystectomy and does not have CMI or MALS, excluded with the help of duplex ultrasound.

No interventions assigned to this group

Blood donor (Young)

Healthy blood donor with a median age of 45 years, who does not have symptoms of mesenteric ischemia or MALS and has excluded these two conditions with the help of duplex ultrasound.

No interventions assigned to this group

Blood donor (Old)

Healthy blood donor with a median age of 70 years, who does not have symptoms of mesenteric ischemia or MALS and has excluded these two conditions with the help of duplex ultrasound.

No interventions assigned to this group

Interventions

Laparoscopic surgery

The patients in the MALS group will be treated through transperitoneal ventral approach for the laparoscopic release of the celiac artery. Median arcuate ligament and any muscle or nerve tissue crossing the cranial surface of the celiac artery will be divided to release the celiac artery from compression.

In the patients with CMI open antegrade or retrograde bypass to celiac artery or superior mesenteric artery or both will be performed.

For operative treatment will be performed in general anaethesia whereas the endovacular treatment with PTA with stent for CMI will be performed in local anaethesia.

Intervention Type: PROCEDURE

Other Intervention Names

Percutaneous transluminal angioplasty (PTA) with stent; Open mesenteric bypass

Eligibility Criteria

Inclusion Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Syed Sajid Hussain Kazmi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Syed Sajid Hussain Kazmi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of vascular surgery, Oslo University Hospital

Locations

Department of vascular surgery, Oslo University Hospital

Oslo, Oslo County, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Syed Sajid Hussain Kazmi, MD, PhD

Role: CONTACT

sshkazmi@gmail.com

4792468309

Facility Contacts

Syed Sajid Hussain Kazmi, MD, PhD

Role: primary

sshkazmi@gmail.com

004792468309

References

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.

Reference Type: BACKGROUND

PMID: 35903288 (View on PubMed)

Other Identifiers

607155

Identifier Type: -

Identifier Source: org_study_id