A Pilot Study on the Using a Newer Computed Tomography (CT) Based Technique for the Detection of Altered Bowel Blood Flow Among Patients Suffering From Chronic Mesenteric Ischemia During Meal Digestion.
Detection of Bowel Hypoperfusion Among Chronic Mesenteric Ischemia Patients During Meal Digestion Using Dual-Energy CT (DECT) - A Pilot Study.
1 other identifier
interventional
20
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedMarch 12, 2021
March 1, 2021
1.1 years
March 9, 2021
March 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pre- and post-operative DECT scans on CMI patients
10 days
Interventions
CMI patients planned for endovascular stent placement will be contacted and informed about this study prior to their procedure. If they wish to take part in the study, then a date for a pre-operative DECT scan will be arranged. Before scanning the patient will be given a standardized calorie dense drink (Nutridrink). This will take place one week prior to their surgical procedure. Following the surgical procedure, the patient will undergo another DECT scan before discharge.
Eligibility Criteria
You may qualify if:
- Diagnosed CMI patients planned for endovascular stent placement treatment
You may not qualify if:
- Noncomplete dataset
- Allergies to contrast agents
- Suboptimal CT images
- Issues related to the administration of the calorie drink
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD-student
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 12, 2021
Study Start
May 1, 2021
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
March 12, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share