To evaluate the use of the early serum markers I-FABP, D-dimer, DAO and alpha-GSTin predicting CGI one by one.To evaluate the use of Citrulline to determine the bowel function in patients with CGI.
ID
Source
Brief title
Condition
- Gastrointestinal vascular conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Test results serological markers
Secondary outcome
Data that will be recorded are:
§ Pathology on referral
§ Demographic data:
o Age
o Gender
o Ethnicity
o Body length and weight
§ Physical examination
§ Cardiovascular risk factors
§ Alcohol and tobacco use
§ Medication use
§ Medical history
§ Family history
§ Test results sugar absorption test
Background summary
Diagnosing chronic gastrointestinal ischemia (CGI) is a challenging problem.
There is no single, simple test with a high sensitivity available to detect
this condition. Presenting symptoms of CGI are postprandial pain, which may
lead to weight loss typically caused by fear of eating, exercise related pain
and diarrhoea. At the moment, patients referred for evaluation of possible CGI
are evaluated using computed tomography angiography (CTA) and 24 hour gastric
and jejunal tonometry (24hrTM). Patients with abdominal arterial stenosis on
CTA and abnormal 24hrTM (i.e. GI ischemia) are advised to undergo treatment.
CTA is a minimally invasive technique to detect and define abdominal artery
stenoses, while 24hrTM measures ischemia defined as insufficient oxygen
delivery and/or consumption of the metabolic demands. However, 24hrTM is an
invasive and cumbersome procedure to perform. Serum markers for CGI would be of
great value in diagnosing these patients and contribute to the diagnostic
properties as a single, non-invasive test method.
This study is performed to further establish the potential role of serum
ischemia markers in patients analyzed for possible CGI. Several early serum
markers will be tested and compared to the results of a functional test for CGI
(24hrTM) and visualization of the abdominal arteries (CTA).
Study objective
To evaluate the use of the early serum markers I-FABP, D-dimer, DAO and
alpha-GST
in predicting CGI one by one.
To evaluate the use of Citrulline to determine the bowel function in patients
with CGI.
Study design
A prospective patient-control pilot study conducted by the Department of
Gastroenterology & Hepatology, Erasmus MC University Medical Center Rotterdam.
Study burden and risks
Patients will be evaluated according to the CGI work-up using CTA and 24hrTM.
During 24hrTM patients receive intravenous infusion of omeprazole. From the
same catheter, 5 blood samples will be drawn (total 165 ml). A non-invasive
sugar absorption test in urine will be performed during this admission, which
will not be prolonged by participating in this study.
Healthy volunteers:
1. Physical examination, cardiovascular risk factors
2. A non-invasive duplex ultrasound will be performed after 6 hours fasting.
3. Subsequently, after insertion of an intravenous catheter with minimal risks,
a blood sample will be drawn at baseline, 30 minutes, 1, 2 and 4 hr after a
standard liquid compound meal (total 165 ml).
All volunteers will be offered expense allowance and receive ¤ 50,- for
participating in the study.
's-Gravendijkwal 230
3015 CE Rotterdam
Nederland
's-Gravendijkwal 230
3015 CE Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
>18 years old
Exclusion criteria
Use of NSAID*s, ascal, acetylsalicylic acid, acenocoumarol
Pregnant or lactating women
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 | NL22082.078.08 |