Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia

NCT06468774 | Recruiting

• 1 other identifier: 607155
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intestinal ishchemia biomarker; alpha GST; MALS; Chronic mesenteric ischemia

Outcome Measures

Primary Outcomes (1)

• 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 in ng/mL before and after the intervention will be compared seperately for the differnt study groups.

  3 months

Secondary Outcomes (6)

• Health related quality of life (QoL)

  5 years

• Clinical outcomes of the treatment of CMI and MALS

  10 years

• Cost utility analysis of the treatment of CMI and MALS

  5 years

• Intestinal ishemia biomarkers for CMI and MALS

  3 months

• Plasma citruline

  3 months

Study Arms (6)

Median arcuate ligament syndrome (MALS)

Patients with MALS Scheduled for laparoskopic decompression.

Procedure: Laparoscopic surgery

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.

Procedure: Laparoscopic surgery

Morbus Crohn intestine

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

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.

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.

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.

Interventions

Laparoscopic surgery 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.

Also known as: Percutaneous transluminal angioplasty (PTA) with stent, Open mesenteric bypass

Chronic mesenteric ischemia (CMI); Median arcuate ligament syndrome (MALS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of vascular surgery, Oslo University Hospital

Oslo, Oslo County, Norway

RECRUITING

Related 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.

  PMID: 35903288 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma Alpha glutathione S transferase (Alpha GST)

MeSH Terms

Conditions

Median Arcuate Ligament Syndrome; Crohn Disease; Cholelithiasis

Interventions

Laparoscopy; Angioplasty

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Arterial Occlusive Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Investigative Techniques

Study Officials

• Syed Sajid Hussain Kazmi, MD, PhD

  Department of vascular surgery, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Sajid Hussain Kazmi, MD, PhD

CONTACT

4792468309; sshkazmi@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 21, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): May 31, 2037
• Study Completion (Estimated): May 31, 2037
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

NO (1)