Chronic Mesenteric IschemiaNCT02914912
Investigation of Chronic Intestinal Ischemia
An observational study of Chronic Mesenteric Ischemia, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
Patients suspected of chronic mesenteric ischemia caused by atherosclerosis or median arcuate ligament syndrome shall be investigated with trans mucosal and transserosal laser Doppler flowmeter and visible light spectroscopy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Mesenteric Ischemia
- How many people
- 100 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2016to Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients suspected of chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome and confirmed with CTA, duplex ultrasound, and clinical examination shall be included in the study. The included patients are referred to the Department of Vascular Surgery for investigation and treatment of the CMI and MALS.
Who may be able to join
- Clinical chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome
Who cannot join
- Patients unable to go through gastroscopy
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University Hospital
Oslo, 0424
Department of vascular surgery, Oslo University Hospital
Oslo
About this study
Patients suspected of chronic mesenteric ischemia caused by atherosclerosis or median arcuate ligament syndrome shall be investigated with trans mucosal and transserosal laser Doppler flowmeter and visible light spectroscopy.
Read the detailed description
Patients with suspected chronic mesenteric ischemia (included median arcuate ligament syndrome/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 investigated
- with gastroscopy-assisted laser Doppler flowmetry and light spectroscopy (GALS) before and after the surgical or endovascular treatment
- Endoscopic ultrasound before and after the surgical or endovascular treatment
- Transserosal laser Doppler flowmetry and light spectroscopy during the surgical treatment
- Plasma Ischemia bio-markers, before and after the surgical or endovascular treatment
- Health related quality of life assessed with EQ5D and SF36 before and after the treatment
- clinical outcomes of the treatment (early and late results).
- Conditions
- Chronic Mesenteric Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GALS symptomatic patients group | Patients with chronic mesenteric ischemia (CMI) symptoms shall be investigated with gastroscopy-assisted laser Doppler flowmetry and visible light spectroscopy. The examination will be performed before and after the surgical or endovascular treatment for CMI. Besides, the patients treated with either open or laparoscopic mesenteric bypass shall be examined during the operation with transserosal microcirculatory assessment of the stomach and duodenum using laser Doppler flowmetry and visible light spectroscopy. | |
| CMI caused by median arcuate ligament syndrome (MALS) | Patients with chronic mesenteric ischemia (CMI) symptoms caused by MALS shall be investigated with gastroscopy-assisted laser Doppler flowmetry and visible light spectroscopy. The examination will be performed before and after the surgical or endovascular treatment for MALS. Besides, the patients treated with an either open or laparoscopic technique for MALS shall be examined during the operation with transserosal microcirculatory assessment of the stomach and duodenum using laser Doppler flowmetry and visible light spectroscopy. | |
| Healthy individuals without CMI or MALS | A group of healthy individuals with no symptoms of CMI or MALS shall be investigated with gastroscopy-assisted laser Doppler flowmetry and visible light spectroscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transmucosal Oxygen concentration of the stomach and duodenum
Repeated measurments at baseline 3, and 12 months after the surgical or endovascular treatment of chronic mesenteric ischemia (CMI) and median arcuate ligament syndrome (MALS) shall be performed. With the help of gastoscopy assisted Laser Doppler flowmeter and visible light spectroscopy, transmocosal SaO2, rHb concentration, flow and velocity in arbitrary units shall be measured.
Measured: Baseline, 3 months and 12 months
Secondary outcomes (4)
Ischemia biomarkers
Plasma levels of intestinal ischemia biomarkers, alpha glutathione s transeferase, intestinal fatty acid binding protein, human immune modified globulin and plasma citrolline shall be examined before and after the surgical or endovascular treatment of the patients with either open or laparoscopic surgery, or endovascular treatment. Blood samples from a cohort of healthy individuals without any symptoms of CMI or MALS shall be tested for the same ischemia biomarkers.
Measured: 10 years
Health-related quality of life in the patients with chronic mesenteric ischemia
Quality of life assesment at baseline and after treatment with EQ-5D
Measured: 10 years
Clinical outcomes of revascularization in the patients with chronic mesenteric ischemia
Chronic mesenteric ischemia and median arcuate ligament syndrome patients treated with either open/ laparoscopic vascular surgery or endovascular treatment shall be routinely followed-up at the out-patients department for the results of the treatment and the 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. Besides the patency of the revascularized mesenteric artery will be determined with duplex ultrasound.
Measured: 10 years
Transserosal microcirculation assessment
The patients with MALS and CMI treated with an either open or laparoscopic surgery shall be examined with transserosal Laser Doppler flowmetery and visible light spectroscopy of the stomach and duodenum during the operation. Transserosal SaO2, relative Hb concentration, blood flow and velocity in arbitrary units will be measured with the Laser doppler flowmeter and visible light spectroscope applaied directly to the surface of stomach and duodenum under the surgical procedure.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Mesenteric IschemiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Sajid Hussain Kazmi, Oslo University Hospital
- Investigators
- Syed Sajid Hussain Kazmi, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914912
- Sponsor's protocol ID
- 2016/682
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2016
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The PI can share anonymous study data after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Chronic Intestinal Ischemia
- ClinicalTrials.gov ID
- NCT02914912
- Acronym / sponsor ID
- 2016/682
- Conditions
- Chronic Mesenteric Ischemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients suspected of chronic mesenteric ischemia caused by atherosclerosis or median arcuate ligament syndrome shall be investigated with trans mucosal and transserosal laser Doppler flowmeter and visible light spectroscopy.
Detailed description
Patients with suspected chronic mesenteric ischemia (included median arcuate ligament syndrome/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 investigated
- with gastroscopy-assisted laser Doppler flowmetry and light spectroscopy (GALS) before and after the surgical or endovascular treatment
- Endoscopic ultrasound before and after the surgical or endovascular treatment
- Transserosal laser Doppler flowmetry and light spectroscopy during the surgical treatment
- Plasma Ischemia bio-markers, before and after the surgical or endovascular treatment
- Health related quality of life assessed with EQ5D and SF36 before and after the treatment
- clinical outcomes of the treatment (early and late results).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GALS symptomatic patients group | – | –Patients with chronic mesenteric ischemia (CMI) symptoms shall be investigated with gastroscopy-assisted laser Doppler flowmetry and visible light spectroscopy. The examination will be performed before and after the surgical or endovascular treatment for CMI. Besides, the patients treated with either open or laparoscopic mesenteric bypass shall be examined during the operation with transserosal microcirculatory assessment of the stomach and duodenum using laser Doppler flowmetry and visible light spectroscopy. |
| CMI caused by median arcuate ligament syndrome (MALS) | – | –Patients with chronic mesenteric ischemia (CMI) symptoms caused by MALS shall be investigated with gastroscopy-assisted laser Doppler flowmetry and visible light spectroscopy. The examination will be performed before and after the surgical or endovascular treatment for MALS. Besides, the patients treated with an either open or laparoscopic technique for MALS shall be examined during the operation with transserosal microcirculatory assessment of the stomach and duodenum using laser Doppler flowmetry and visible light spectroscopy. |
| Healthy individuals without CMI or MALS | – | –A group of healthy individuals with no symptoms of CMI or MALS shall be investigated with gastroscopy-assisted laser Doppler flowmetry and visible light spectroscopy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suspected of chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome and confirmed with CTA, duplex ultrasound, and clinical examination shall be included in the study. The included patients are referred to the Department of Vascular Surgery for investigation and treatment of the CMI and MALS.
Key inclusion criteria (1 listed)
- Clinical chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome
Key exclusion criteria (1 listed)
- Patients unable to go through gastroscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transmucosal Oxygen concentration of the stomach and duodenum
Time frame: Baseline, 3 months and 12 months
Repeated measurments at baseline 3, and 12 months after the surgical or endovascular treatment of chronic mesenteric ischemia (CMI) and median arcuate ligament syndrome (MALS) shall be performed. With the help of gastoscopy assisted Laser Doppler flowmeter and visible light spectroscopy, transmocosal SaO2, rHb concentration, flow and velocity in arbitrary units shall be measured.
4 secondary outcomes
Ischemia biomarkers
Time frame: 10 years
Health-related quality of life in the patients with chronic mesenteric ischemia
Time frame: 10 years
Clinical outcomes of revascularization in the patients with chronic mesenteric ischemia
Time frame: 10 years
Transserosal microcirculation assessment
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. The PI can share anonymous study data after completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Sajid Hussain Kazmi, MD PhD principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Mesenteric Ischemia, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transmucosal Oxygen concentration of the stomach and duodenum (time frame: Baseline, 3 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.