Facilitating diagnosis of chronic mesenteric ischemia (CMI) using 1) the mesenteric artery calcium score (MACS) and 2) mucosal ischemia detection by butyrate breath testing
ID
Source
Brief title
Condition
- Gastrointestinal vascular conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) MACS: An existing abdominal CT is used to calculate the MACS of the celiac
artery and superior mesenteric artery.
2) Butyrate breath testing: Patients will receive 13C-butyrate dissolved in a
high caloric drink (Nutridrink). Multiple test tubes filled with expired air of
13CO2 will be collected during a period of 2 hours.
Secondary outcome
- To determine cut of values for the MACS with high specificity and high
negative predictive value.
- To validate the symptom and CT based MACS score chart for early risk
stratification of patients with suspected CMI.
- To investigate how CMI affects the gut microbioma and which specific
microbial DNA fragments in blood can indicate ischemic damage to the intestinal
tissue measured before and after stentplacement
- To assess if specific DNA fragments in blood, associated with cell death due
to ischemia, could serve as potential biomarkers for the severity and presence
of CMI
- To investigate the difference of cytokeratin fragments in blood before and
after stent placement, and which fragments can serve as diagnostic markers for
the type and location of cell death in intestinal ischemia?
Background summary
CMI is an incapacitating disease and timely diagnosis remains problematic.
Despite the substantial compensatory capacity of the mesenteric circulation CMI
is relatively common, its incidence being comparable to other well-known
diseases like Crohn's disease.
Diagnostic tools are needed for two purposes since the exclusion of CMI
currently requires a cumbersome complication-prone diagnostic workup and since
a definitive diagnosis is mainly established per exclusionem. First, a
sensitive test is desirable to rule out CMI and avoid excessive diagnostic
investigations. Quantification of mesenteric arterial calcification on computed
tomography (CT) seems suitable for this purpose, synonymous with the coronary
artery calcium score. Second, a specific test is required confirming CMI by
detection of mucosal ischemia during a meal, when oxygen demand peaks. A breath
test, based on the requirement of oxygen to absorb and metabolize 13C-butyrate
in the enterocyte, could detect mucosal ischemia
Study objective
Facilitating diagnosis of chronic mesenteric ischemia (CMI) using 1) the
mesenteric artery calcium score (MACS) and 2) mucosal ischemia detection by
butyrate breath testing
Study design
Multicentre prospective cohort studies.
Study burden and risks
1) MACS:
Patients participating in the MACS part of the study will not experience an
additional burden due to the study. Data will be collected during standard
intake and follow-up visits, and comprises of data registered in the medical
files of all patients, regardless of participation in the study. The MACS is
calculated on already available CT images or on CTA images obtained during the
standard diagnostic workup, additional imaging for study purposes is not
required.
2)Breath test:
Patients participating in the breath test part of the study will visit the
hospital to perform a breath test with a 2 hour duration. We intend to combine
the breath test with other hospital visits to avoid the burden of extra
hospital visits. During the breath test, patients will take a high caloric
drink containing 13C-butyrate. The high caloric drink might provoke the
postprandial abdominal discomfort that patients usually experience. No
additional discomforts or side-effect are expected of 13C-butyrate since both
substances are stable isotopes. The breath test itself is non-invasive,
patients are asked to fully exhale through a straw into a test-tube.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Patients >= 18 years
- Patients with a clinical suspicion of CMI referred to the hospital
Exclusion criteria
- Patients who are unable to give informed consent
- No available CT imaging and contraindications for CT imaging (e.g. pregnancy)
- Patients with previous mesenteric artery revascularization
- Common origin of the celiac artery and superior mesenteric artery
- Known delayed gastric emptying
- Known and untreated small intestinal bacterial overgrowth
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83632.078.23 |