1) To assess the the natural course of atherosclerotic disease in the carotid artery. 2) to evaluate whether a change in plaque volume, composition and morphology can be predicted based on risk factor profiles, baseline plaque status and shear…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in atherosclerotic plaque volume, plaque composition and plaque
morphology in the carotid artery
Secondary outcome
1) Recurrent ipsilateral cerebrovascular event.
2) Ischemic stroke, myocardial infarction or vascular death
Background summary
It has been recognized that atherosclerotic plaque composition and morphology
could be much more important than luminal stenosis for the development of acute
neurovascular events: plaques consisting of a necrotic core covered by a thin
fibrous cap are prone to rupture leading to thrombo-embolic events. Despite
this concept, not much is known about the natural course of atherosclerotic
disease in the carotid arteries.
In this project we will evaluate atherosclerotic carotid plaque features
(plaque volume, plaque composition, plaque morphology, shear stress) with MDCTA
Study objective
1) To assess the the natural course of atherosclerotic disease in the carotid
artery.
2) to evaluate whether a change in plaque volume, composition and morphology
can be predicted based on risk factor profiles, baseline plaque status and
shear stress and
3) To assess the predictive value of atherosclerotic plaque features (both
baseline and changes) for risk of recurrent ipsilateral stroke?
Study design
Observational prospective study
Study burden and risks
In this study an extra MDCTA of the carotid artery is performed. Participants
have to visit the hospital for this examination. An extra MDCTA requires
additional ionizing radiation, which is within the international acceptable
limits. MDCTA requires injection of contrast agents. This agents can provoke an
allergic reaction and a decrease in renal function. In persons with a higher
risk for renal insufficiency, a recent renal function has to be available.
During follow-up, the participants will be contacted once a year for a
questionnaire which will take 15 minutes.
Benefits: There is no individual benefit. In case a carotid atherosclerotic
stenosis has increased during follow-up to more than 70%, participants will be
referred to a neurologist to discuss an intervention (surgery or stent
placement).
's Gravendijkwal 230
3015 CE
NL
's Gravendijkwal 230
3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Patients with cerebrovascular symptoms (amaurosis fugax, hemispheric TIA or minor stroke (Rankin < 3)) who had visited the department of Neurology. The neurologist examined the patient and decided whether the neurological symptoms can be considered to be caused by cerebral ischemia
- Patients had undergone MDCTA of the carotid arteries
- the presence of atherosclerotic disease in the carotid artery as seen on
MDCTA.
- signed Informed consent
Exclusion criteria
·contrast material allergy
·renal insufficiency defined as eGFR <= 60 mL/min
·no 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 | NL24449.078.08 |