Multi-contrast Versus Multi-sequence Carotid MRI

NCT04569006 | Recruiting

• 1 other identifier: ABR73156
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

40 patients (18 years or older) with a carotid plaque ≥ 2 mm based on ultrasound or CTA, will be included in this study. These patients will undergo a 3T MRI scan. Inclusion will be done by an investigator. All the research will take place at Maastricht University Medical Centre (MUMC). Vascular surgeons, neurophysiologists and neurologists at MUMC are willing to participate in this study. Some of the included patients will be scheduled for CEA as part of standard clinical care. The MRI scan of these patients will take place at least one day before CEA is performed. At MUMC, approximately 10 patients per month fit the criteria (≥ 2 mm carotid plaque size).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Carotid plaque tissue retrieved only from patients undergoing carotid endarterectomy for regular patient care.

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 29, 2020
• Study Start: April 8, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)