Measurement of local arterial stiffness in the carotid artery in subjects at low and high cardiovascular risk and in patients with recent ischaemic cerebrovascular events.
- Conditions
- arterial stiffnesscardiovascular risk10003216
- Registration Number
- NL-OMON43542
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
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 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The principal parameter is the difference in local PWV as measured by MRI at<br /><br>three different points in the carotid artery in (symptomatic and asymptomatic)<br /><br>patients with carotid plaque formation and in healthy controls. </p><br>
- Secondary Outcome Measures
Name Time Method <p>As secondary parameters we will consider the difference in vessel wall<br /><br>dimensions, wall shear stress and PWV between healthy subjects and<br /><br>(symptomatic and asymptomatic) cardiovascular patients.</p><br>