Level of Agreement in the Assessment of Carotid Plaque Composition Between Multi-contrast and Multi-sequence MRI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Presence of Intra Plaque Hemorrhage (IPH)
Study Overview
Brief Summary
The objective of this study is to validate 2 multi-contrast sequences, namely the Multi-contrast ATherosclerosis Characterization (MATCH) and Bright-blood and black-blOOd phase SensiTive (BOOST) inversion recovery sequence for the quantification of atherosclerotic plaque components with conventional multi-sequence MRI and histology.
Detailed Description
Rationale: Rupture of a vulnerable atherosclerotic plaque is the most important cause of stroke and myocardial infarction. Magnetic Resonance Imaging (MRI) with its high soft tissue contrast is well suited for atherosclerotic plaque imaging to identify high-risk plaques. High soft tissue contrast enables the visualisation of different plaque components based on which the plaque can be classified as stable or vulnerable. To identify the various plaque components, in a conventional MRI examination multiple MRI sequences are acquired, which can take approximately 30-40 minutes. This can be uncomfortable for the patient and it is impractical in daily clinical practice. As an alternative, multi-contrast sequences have recently been developed which acquire multiple contrast weightings simultaneously, significantly reducing the scan time (< 6 minutes). Apart from a reduction in scan time, because these contrast weightings are acquired simultaneously, they are inherently co-registered which is not the case with conventional sequences.
Objective
The objective of this study is to validate 2 multi-contrast sequences, namely the Multi-contrast ATherosclerosis Characterization (MATCH) and Bright-blood and black-blOOd phase SensiTive (BOOST) inversion recovery sequence for the quantification of atherosclerotic plaque components with conventional multi-sequence MRI and histology.
Study design: cross-sectional validation study Study population: 40 patients with a carotid artery plaque ≥2 mm based on ultrasound or Computed Tomography Angiography.
Intervention (if applicable): not applicable Main study parameters/endpoints: the presence and volumetric measures of plaque components (fibrous tissue, lipid-rich necrotic core, intraplaque hemorrhage and calcifications) and volumetric measures of the vessel wall and lumen as assessed with multi-contrast MRI will be compared to those as assessed by conventional multisequence MRI and, if available, histology of the surgically removed specimen in patients that are scheduled for carotid endarterectomy.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet the following criteria:
- •Patients with a carotid plaque ≥ 2 mm thick based on ultrasound or CTA
- •Age 18 years or older (no maximum age)
- •Informed consent by signing informed consent form regarding this study
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Patients with carotid plaque ≤ 2 mm in size based on ultrasound or CTA
- •Standard contra-indications for MRI (electronic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc.)
- •Severe co-morbidity, dementia or pregnancy
Outcomes
Primary Outcomes
Presence of Intra Plaque Hemorrhage (IPH)
Time Frame: through study completion, an average of 6 months
The primary objective is to investigate the level of agreement between scoring presence of IPH on MR images acquired with MP-RAGE (conventional sequence) with scoring IPH on the multi-contrast sequences. The level of agreement will be assessed by calculating Cohen's k.
Secondary Outcomes
- Scoring the presence of other plaque tissues(through study completion, an average of 6 months)
- Calculate correlation between plaque tissues(through study completion, an average of 6 months)
- Correlation between plaque tissues components and histology(through study completion, an average of 6 months)