Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04794959 |
| Other study ID # |
H-20066374 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2021 |
| Est. completion date |
June 2022 |
Study information
| Verified date |
March 2021 |
| Source |
Rigshospitalet, Denmark |
| Contact |
Jack J Xu, MD |
| Phone |
+4525122159 |
| Email |
jack.junchi.xu[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chronic meseteric ischemia (CMI) is a disease characterized by an insufficient blood supply
to the intestines due to a narrowing (stenosis) of one or multiple intestinal arteries. The
primary symptom is abdominal pain especially during meal digestion. Currently the diagnosis
of CMI is heavily reliant on the exclusion of differential diagnoses. With this study we wish
to evaluate whether a newer CT technology called dual-energy CT (DECT) may be able to
visualize this altered blood flow during meal consumption.
Description:
CMI is a relatively rare condition mainly affecting elderly patients >60 years old. CMI is
characterized by an insufficient blood supply to the intestines due to a narrowing (stenosis)
of one or multiple intestinal arteries. The main symptoms associated with CMI are abdominal
pain following mealtimes and weight loss. Diagnosis for CMI is difficult as >10% of all
elderly patients have stenotic changes in their intestinal arteries, however only a fraction
of these patients are symptomatic. The diagnosis of CMI is therefore mainly based on the
clinical history and evaluation. The challenging diagnosis is most likely the main
contributing factor to why five to 19% of patients experience no symptomatic relief following
surgical treatment. The surgical treatment consists of either open surgical bypass or, more
commonly, endovascular stent placement, opening the stenotic artery.
Endovascular stent placement for patients with symptomatic CMI is a common procedure at the
Department of Diagnostic Radiology and Department of Vascular Surgery, Rigshospitalet, with
approximately 60 patients undergoing the procedure annually. Patients undergo a preoperative
CT scan including a non-contrast and arterial phase scan to evaluate the abdominal arterial
vessels and the degree of stenosis, however the bowel wall is not routinely evaluated. This
is mainly due to the fact that mesenteric blood flow is adequate during times of fasting,
however insufficient blood flow may occur at times of peak demand i.e. during digestion of a
meal.
DECT has shown improved conspicuity for bowel ischemia using monoenergetic images and allows
for iodine selective maps which have been used in the evaluation of pulmonary emboli.
To our knowledge, there are no current studies that have investigated applications of DECT in
the evaluation of CMI. We intend to investigate whether it is possible to visualize bowel
hypoperfusion using DECT following administration of a standardized meal.
