Study to investigate possible applications for MRI and ultrasound in the diagnosis of atherosclerosis of the carotid artery.

Study to investigate the sensitivity and specificity of 3.0 Tesla MRI, MRS and ultrasound imaging for carotid artery plaque dimension and composition assessment.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26704

Enrollment

Registered

2010-07-14

Start date

2010-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Patients with a &#8805

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients are to meet the inclusion criteria of the Athero-Express study; 2. These patients are eligible to undergo carotid endarterectomy in either the St. Antonius Hospital, Nieuwegein; 3. Willing and able to undergo non-invasive MRI, MRS and ultrasound examinations in the Academic Hospital Center, Amsterdam; 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients not suitable for MRI (e.g. metal in the body, as a result of pacemaker or artificial cardiac valves); 2. Claustrophobia; 3. Surgery performed in the neck area of the carotid measurements.

Design outcomes

Primary

Measure	Time frame
To investigate sensitivity and specificity of 3.0 Tesla MRI and MRS for dimension and composition assessment of carotid artery plaques, in particularly those plaques with lipid rich necrotic cores. 1. Total plaque volume, plaque calcification volume, plaque haemorrhage volume, lipid rich necrotic core volume, fibrous cap thickness, as assessed by 3.0 Tesla MRI; 2. The ratio of the integrated lipid peak versus the unsuppressed water peak (expressed as a percentage), as assessed by MRS; 3. Carotid plaque presence and location, maximum plaque thickness and plaque composition, as assessed by B-mode ultrasound imaging; 4. Carotid intima-media thickness, arterial stiffness, blood flow velocity measured by B-mode ultrasound imaging. Histology. 5. Plaque size, morphology and phenotype (presence of collagen, smooth muscle cells, calcifications, macrophages, thrombus and fat), as assessed by histology analysis. For the comparison of histology and MRI, MRS and ultrasound images the histological images are matched by observing the overall morphology such as lumen size and shape, wall size and shape, plaque configuration, as well as calcifications, landmarks of the plaque and the known distance of each slice from the common carotid bifurcation. Histology slices will be matched with MR images and ultrasound images based on anatomical landmarks.	—

Measure

Time frame

To investigate sensitivity and specificity of 3.0 Tesla MRI and MRS for dimension and composition assessment of carotid artery plaques, in particularly those plaques with lipid rich necrotic cores. 1. Total plaque volume, plaque calcification volume, plaque haemorrhage volume, lipid rich necrotic core volume, fibrous cap thickness, as assessed by 3.0 Tesla MRI; 2. The ratio of the integrated lipid peak versus the unsuppressed water peak (expressed as a percentage), as assessed by MRS; 3. Carotid plaque presence and location, maximum plaque thickness and plaque composition, as assessed by B-mode ultrasound imaging; 4. Carotid intima-media thickness, arterial stiffness, blood flow velocity measured by B-mode ultrasound imaging. Histology. 5. Plaque size, morphology and phenotype (presence of collagen, smooth muscle cells, calcifications, macrophages, thrombus and fat), as assessed by histology analysis. For the comparison of histology and MRI, MRS and ultrasound images the histological images are matched by observing the overall morphology such as lumen size and shape, wall size and shape, plaque configuration, as well as calcifications, landmarks of the plaque and the known distance of each slice from the common carotid bifurcation. Histology slices will be matched with MR images and ultrasound images based on anatomical landmarks.

—

Secondary

Measure	Time frame
To investigate sensitivity and specificity of carotid B-mode ultrasound imaging as a pre-screening assessment of carotid plaques for MRI and MRS studies.	—

Contacts

Public ContactStroes

Meibergdreef 9, F4-121

E.S.Stroes@amc.uva.nl

Outcome results