Plasma α-Glutathione S-Transferase in Patients with Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome.
Syed Sajid Hussain Kazmi, Nathkai Safi, Simen Tveten Berge...
https://pubmed.ncbi.nlm.nih.gov/35903288Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID06468774
Intestinal Ischemia Biomarker and Quality of Life in Patients With Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome
Led by Oslo University Hospital · Updated on 2025-07-30
180
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating plasma Alpha glutathione S transferase (Alpha GST) levels in patients with chronic mesenteric ischemia (CMI) and median arcuate ligament syndrome (MALS), conditions that cause abdominal pain and weight loss. The study compares these levels to those in patients with Morbus Crohn, gallstone disease, and healthy individuals, aiming to find better biomarkers for intestinal ischemia and assess changes in quality of life. This observational study includes patients diagnosed by imaging and healthy controls, exploring Alpha GST alongside other potential markers like intestinal fatty acid binding protein, citrulline, and ischemia-modified albumin. Participants receive different treatments based on their condition: patients with MALS undergo laparoscopic surgery to release the celiac artery, while those with CMI receive open bypass surgery or endovascular treatment with PTA and stenting. Control groups include patients scheduled for gallbladder removal or with Crohn's disease, as well as healthy blood donors. Blood samples are collected at inclusion and three months later, with imaging used to confirm diagnoses and exclude conditions in controls. Participants complete questionnaires about symptoms and quality of life, including the EuroQol 5D (EQ-5D), at various points up to 10 years after treatment. Follow-up visits include clinical assessments and duplex ultrasound to monitor outcomes. The study also collects data on treatment complications and costs to analyze quality-adjusted life years and cost-utility. The main outcome measured is plasma Alpha GST levels at three months, with long-term tracking of clinical outcomes and quality of life up to 10 years.
CONDITIONS
Brief Title
Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and has given informed written consent for treatment and study participation
- For patient groups: diagnosed with median arcuate ligament syndrome (MALS) via CTA or ultrasound and scheduled for surgery
- For patient groups: diagnosed with chronic mesenteric ischemia (CMI) via CTA or ultrasound and scheduled for operative or endovascular treatment
- For control groups: diagnosed with cholelithiasis and scheduled for cholecystectomy
- For control groups: established diagnosis of Morbus Crohn under gastric lab follow-up
- For control groups: healthy blood donors with mean age around 45 years, without symptoms of MALS or CMI confirmed by ultrasound
- For control groups: healthy blood donors with mean age around 70 years, without symptoms of MALS or CMI confirmed by ultrasound
You will not qualify if you...
- Age less than 18 years
- Has not given written consent
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including duplex ultrasound to exclude CMI and MALS for control groups
Baseline Assessment
Duration - Up to 1 day at enrollment
Participants undergo blood sampling and symptom questionnaires before treatment or observation.
1 visit (in-person) for blood samples and questionnaires
Treatment
Duration - Single treatment event with immediate post-treatment period
Participants with MALS undergo laparoscopic decompression surgery, and participants with CMI receive operative or endovascular treatment.
1 treatment visit (in-person) plus hospitalization as needed
Post-Treatment Follow-up
Duration - 10 years
Participants are followed up to monitor clinical symptoms, complications, and quality of life after treatment.
Outpatient visits at 1 month, 3 months, 1 year, 2 years, 5 years, and 10 years including duplex ultrasound and questionnaires
Control Group Monitoring
Duration - 3 months
Control group participants have blood sampling and duplex ultrasound at inclusion and after 3 months to monitor biomarker levels and exclude conditions.
2 visits (in-person) at baseline and 3 months
Trial Site Locations
Total: 1 location
1
Department of vascular surgery, Oslo University Hospital
Oslo, Oslo, Norway
Actively Recruiting
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Research Team
S
Syed Sajid Hussain Kazmi, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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