The main goal of this study is to assess the difference in local pulse wave velocity measured at three different points in the left and right carotid artery in healthy subjects and in patients with symptomatic and asymptomatic carotid plaques. As…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The principal parameter is the difference in local PWV as measured by MRI at
three different points in the carotid artery in (symptomatic and asymptomatic)
patients with carotid plaque formation and in healthy controls.
Secondary outcome
As secondary parameters we will consider the difference in vessel wall
dimensions, wall shear stress and PWV between healthy subjects and
(symptomatic and asymptomatic) cardiovascular patients.
Background summary
Atherosclerosis is the main cause of cardiovascular disease. It is a
progressive disease, characterised by the formation of plaques in the vessel
wall. In the past decades, the management of cardiovascular (CV) disease has
been revolutionised by the advent of preventive strategies. Despite a
tremendous improvement with this risk stratification, a number of patients
still remain unidentified until a primary event occurs. Therefore, additional
tools to identify high-risk patients are under evaluation. Global pulse wave
velocity (PWV), an index of arterial stiffness, is considered to be an early
marker of atherosclerosis but can give only little information regarding local
changes in vessels prone to atherosclerotic disease. Therefore, local PWV
assessment through MRI could be of great interest, especially considering than
MRI enable us to assess both functional and morphologic characteristics
Study objective
The main goal of this study is to assess the difference in local pulse wave
velocity measured at three different points in the left and right carotid
artery in healthy subjects and in patients with symptomatic and asymptomatic
carotid plaques. As secondary objectives, we aim to assess the difference in
vessel wall dimensions, wall shear stress, global pulse wave velocity between
healthy subjects and cardiovascular patients and to investigate the correlation
between pulse wave velocity, wall shear stress and atherosclerotic plaque
characteristics.
Study design
Cross-sectional study
Study burden and risks
The results of this study contribute to the quality of novel techniques in
atherosclerotic imaging, thereby contributing to risk stratification in
individual patients and testing of new anti-atherosclerotic treatment.
Individual subjects will gain no direct benefit from this study. The risk of
participating in this study is low. MRI is a safe imaging technique without
radiation exposure. Gadovist is routinely used as a contrast agent in magnetic
resonance imaging.
Meibergdreef 9
Amsterdam 1055AZ
NL
Meibergdreef 9
Amsterdam 1055AZ
NL
Listed location countries
Age
Inclusion criteria
Group 1 : subjects aged >18 years with asymptomatic carotid plaques as assessed by either carotid ultrasound/CT or previous MRI
Group 2 : subjects aged >18 years with symptomatic carotid artery disease as evidenced by a recent TIA or ischaemic stroke in the supply area of the carotid artery in the preceding 8 months not scheduled for intervention
Group 3 : healthy volunteers aged >18 years with no history of cardiovascular disease nor presence of cardiovascular risk factors
Exclusion criteria
Exclusion criteria for all subjects
• Known systemic disorders such as hepatic, renal, haematological and malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator
• Standard contra-indications to MRI based on physicians experience and current practices
• Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study;Exclusion criteria for group 1
• Changes in dose or frequency of doses of lipid-lowering drugs, antihypertensive drugs or antidiabetic drugs in the last 6 weeks prior to baseline measurements
• Cerebrovascular event in the 8 months prior to enrolment;Exclusion criteria for group 2
• Changes in dose or frequency of doses of lipid-lowering drugs, antihypertensive drugs or antidiabetic drugs in the last 6 weeks prior to baseline measurements;Exclusion criteria for group 3
• History of cardiovascular disease
• Presence of risk factors for cardiovascular disease
• Use of any cardiovascular medication, including but not limited to lipid-lowering therapy, antihypertensive drugs, anti-diabetic drugs, platelet aggregation inhibitors and anticoagulants
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 | NL55762.018.15 |