Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468774
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-12
Brief Title:
Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Intestinal Ischemia Biomarker and Quality of Life of the Patients With Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 78 ngmL in patients with CMI caused by atherosclerosis and in patients with MALS 84 ngmL 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 33 ngmL
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 n30 and MALS n30 with those with 1-Morbus Crohn n30 2-Gallstone disease n30 and age-matched healthy individuals n60
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 curveAUC 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
In our previous study we found raised levels of plasma Alpha glutathione S transferase Alpha GST 78 ngmL in patients with CMI caused by atherosclerosis and in patients with MALS 84 ngmL 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 33 ngmL
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 n30 and MALS n30 with those with 1-Morbus Crohn n30 2-Gallstone disease n30 and age-matched healthy individuals n60
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 curveAUC 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None