Investigation of Chronic Intestinal Ischemia

November 23, 2023 updated by: Syed Sajid Hussain Kazmi, Oslo University Hospital
Patients suspected of chronic mesenteric ischemia shall be investigated with gastroscopy-assisted laser Doppler flowmeter and light spectroscopy (GALS).

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Patients with suspected chronic mesenteric ischemia (included truncus coeliacus compression syndrome) referred to the vascular surgery department for investigation of splanchnic and mesenteric circulation shall be included in this study.

In addition to CT angiography, patients shall be

  1. investigated with gastroscopy-assisted laser Doppler flowmetry and light spectroscopy (GALS).
  2. Endoscopic ultrasound
  3. Transserosal laser Doppler flowmetry and light spectroscopy
  4. Ischemia bio-markers
  5. Health related quality of life

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Syed Sajid Hussain Kazmi, MD PhD
  • Phone Number: 004792468309
  • Email: sshkazmi@gmail.com

Study Contact Backup

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital
      • Oslo, Norway
        • Department of vascular surgery, Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pateients suspected With chronic mesenteric ischemia included truncus coeliacus compression syndrome, refered to the vascular surgery Department for investigation.

Description

Inclusion Criteria:

Clinical chronic mesenteric ischemia

Exclusion Criteria:

Patients unable to gå through gastroscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
GALS symptomatic patients group
Patents With symptoms of chronic mesenteric ischemia shall be investigated with GALS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow Laser Doppler flowmeter
Time Frame: Baseline, 3 months and 12 months
Repeated measurments at baseline 3, and 12 months
Baseline, 3 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemia biomarkers
Time Frame: 1-2 years
Plasma levels of intestinal ischemia biomarkers
1-2 years
Health-related quality of life in the patients with chronic mesenteric ischemia
Time Frame: 2 years
Quality of life assesment at baseline and after treatment with EQ-5D
2 years
Clinical outcomes of revascularization in the patients with chronic mesenteric ischemia
Time Frame: 6-7 years
Chronic mesenteric ischemia patients treated with either open vascular surgery or endovascular treatment shall be routinely followed-up at the out-patients department for post operative complications, effect of revascularization on the mesenteric ischemia symptoms, patency of endovascular or open revascularization procedure. Routine clinical follow-up shall be 30 days post operatively, 3 months, 12 months and yearly thereafter.
6-7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Syed Sajid Hussain Kazmi, MD PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimated)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/682

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The PI can share anonymous study data after completion of the study.

IPD Sharing Time Frame

Anonymous data can be available up to two years after completion of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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