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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.

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. - Local PWV assessment with MRI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43542
Enrollment
45
Registered
2016-01-14
Start date
2016-02-29
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arterial stiffness cardiovascular risk

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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: 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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)