Multi-contrast Versus Multi-sequence Carotid MRI

Atherosclerosis Clinical Trial

Official title:

Level of Agreement in the Assessment of Carotid Plaque Composition Between Multi-contrast and Multi-sequence MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04569006
• Other study ID #: ABR73156
• Status: Recruiting
• Start date: April 8, 2021
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Intra Plaque Hemorrhage (IPH)	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.	through study completion, an average of 6 months
Secondary	Scoring the presence of other plaque tissues	In addition, we will report the sensitivity and specificity of scoring the presence of IPH, a LRNC, calcifications, a thin or rupture fibrous cap, and ulcerations using the multi-contrast images with the scores based on the conventional multi-sequence images as reference standard.	through study completion, an average of 6 months
Secondary	Calculate correlation between plaque tissues	To study the correlation between the vessel wall and luminal volume and volumes of calcifications, LRNC and IPH as delineated on the multi-contrast sequences versus the conventional multisequence MRI protocol.	through study completion, an average of 6 months
Secondary	Correlation between plaque tissues components and histology	To study the correlation between the presence/volume of calcifications, LRNC, thin or ruptured fibrous cap, ulcerations and IPH as quantified using the multi-contrast MRI sequences and histology.	through study completion, an average of 6 months