1. How accurate is IMT assessment by physicians at the vascular outpatient clinic compared with measurement at the vascular laboratory?2. How accurate is characterisation of severity of the plaque assessed by physicians at the vascular outpatient…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint
1. accuracy of IMT assessment when measured at the OPD
2. accuracy of characterisation of severity of the plaque when measured at the
OPD
These results will be compared with the measurements at the vascular laboratory
as a *gold standard*.
Secondary outcome
none.
Background summary
The development of a practically applicable tool in an outpatient setting could
aid in the decision process by further stratifying CVD risk. IMT-and plaque
assessment may provide such a tool. We hypothesize that in patients at
intermediate risk for CVD, as assessed by established risk calculating
algorithms, an on-site estimation of IMT and plaque will lead to more accurate
identification of vascular status through visualizing the presence or absence
of atherosclerotic damage. If so, adding actual vascular status to the outcome
of established algorithms will become an important tool in daily practice. This
is the first study evaluating atherosclerosis imaging in a specialised vascular
clinic to redefine at risk patients.
Study objective
1. How accurate is IMT assessment by physicians at the vascular outpatient
clinic compared with measurement at the vascular laboratory?
2. How accurate is characterisation of severity of the plaque assessed by
physicians at the vascular outpatient clinic compared with measurement at the
vascular laboratory?
Study design
Every new patient at the vascular outpatient department will undergo regular
anamnesis and physical examination. Every patient will be asked to give a blood
sample in advance of the visit to the vascular outpatient department (which is
standard and not especially for this study).
Every new patient will undergo an ultrasound examination of the common carotid
artery to determine intima-media thicknes and the presence and aspect of plaque.
Informed consent will be asked for the performance of a second ultrasound at
the vascular outpatient department and for use of the clinical information and
ultrasound results for research.
Study burden and risks
Anamnesis, physical examination, drawing of blood and ultrasound examination at
the outpatient department will be performed as a standard procedure and is not
performed especially for this study; the ultrasound at the vascular laboratory
will be extra.
Albinusdreef 2
2333ZA Leiden
Nederland
Albinusdreef 2
2333ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
All patients referred to the vascular outpatient department will be included.
Exclusion criteria
Patient not signing informed consent
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 | NL21890.058.08 |