The goal of this study is to investigate whether BOLD MRI can predict the occurrence of buttock claudication after coiling of the internal iliac arty. The BOLD technique will be used to measure blood supply parameters of the gluteal muscle during…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study outcomes are the BOLD-signal specific outcomes. These parameters
give an indication of the reserve and recovery capacity of the blood supply to
the gluteal muscles. Furthermore, the presence or absence of buttock
claudication will be monitored to correlate the BOLD-signal parameters with and
to determine the predictive value of the technique.
Secondary outcome
n.a.
Background summary
20% of patients with an abdominal aneurysm have a concomitant aneurysm in the
iliac arteries. To enable a safe landing zone and prevent endoleaks, coiling of
the internal iliac artery is indicated. This coiling, however, leads to
persistent buttock claudication in 30% of the patients due to a deprived blood
supply. A correct prediction of the chance of buttock claudication can be
incorporated in the treatment to improve patient care. Currently, no predictive
methods for buttock claudication are available. The MR techniques which will be
investigated in this study might be useful predicting buttock claudication due
to coiling of the internal iliac artery.
Study objective
The goal of this study is to investigate whether BOLD MRI can predict the
occurrence of buttock claudication after coiling of the internal iliac arty.
The BOLD technique will be used to measure blood supply parameters of the
gluteal muscle during and after ischemia of the muscle. The measured parameters
will be correlated with the occurrence of buttock claudication.
Study design
Explorative MR imaging study by measuring BOLD-signal after induced ischemia.
The study is divided into two sub-studies. Sub-study 1 investigates the
predictive value of a non-invasive technique to acquire the BOLD-signal and
will be a cross-sectional cohort study. Sub-study 2 investigates the predictive
value of an invasive technique to induce the BOLD-signal and is designed as an
observational prospective cohort study.
Study burden and risks
The burden and risk of this study for the patient is minimal.
The patients and volunteers in sub-study 1 will receive an MRI scan for a
maximum of 30 minutes, where they are asked to actively contract the gluteal
muscle for 4 times 30 seconds alternated by 15 seconds of rest. Especially
patients with buttock claudication may experience discomfort during the
contraction. They can stop the contraction whenever the discomfort is too high,
afterwards symptoms will diminish. Patients are asked to fill in two
questionnaires to score the extend of buttock claudication
The 10 patients scheduled for EVAR with coiling from sub-study 1 will also
participate in sub-study 2. The artery occlusion and MR scan will be performed
under general anesthesia. The patient will be transferred between two adjacent
rooms, increasing anesthesia time with approximately 45 minutes. Furthermore,
they should also fill the two questionnaires after 3 and 12 months.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
group 1: 5 patients 1 year or longer after EVAR with coiling of internal iliac
artery and with persistent buttock claudication
group 2: 5 patients 1 year or longer after EVAR with coiling of internal iliac
artery and without persistent buttock claudication
group 3: 10 patients scheduled for EVAR with coiling of internal iliac artery
group 4: 10 volunteers without intermittent claudication
Exclusion criteria
Claustrophobia for MRI
<18 years old
No informed consent
Symptomatic- or ruptured aneurysm
MR related exclusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL72133.091.19 |
OMON | NL-OMON27776 |