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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36476

Enrollment

150

Registered

2009-11-23

Start date

2009-09-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

atherosclerosis n/a

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: carotid artery stenosis, > 70 %, scheduled for carotid endarterectomy

Exclusion criteria

Exclusion criteria: Not suitable for MRI (e.g. metal in the body, e.g. as a result of pacemaker or artificial cardiac valve implant), claustrophobia, former surgical procedures in the carotid area

Design outcomes

Primary

Measure	Time frame
Imaging 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 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.	—

Measure

Time frame

Imaging 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 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.

—

Secondary

Measure	Time frame
no secundary study parameters	—

Countries

Netherlands

Outcome results