3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery

Study Overview
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Brief Summary
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This is a technical development study with the goal to develop 3D techniques for atherosclerosis plaque characterization. We hypothesize that 3D MRI is superior to 2D MRI in characterizing major plaque constituents that contribute to severe clinical events such as myocardial infarction or stroke. The major advantages of the 3D techniques to be developed will include high spatial resolution, reduced scan times, and optimized image contrast. The use of contrast injection is not needed with the new techniques, which is greatly beneficial for patients with advanced chronic kidney disease.This is not a funded clinical trial.

Detailed Description
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All participants will undergo the conventional MRI protocol and the new imaging protocol using our developed techniques. They may have either non-contrast scans or contrast-enhanced scans or both depending on the stage of development. The comparison results between the two protocols will be used to evaluate the performance of the new techniques and help optimization of specific technical aspects.

Official Title
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3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery

Conditions
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Carotid Artery Disease

Intervention / Treatment
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* Other: MRI with/without contrast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Volunteers: male or female ≥ 18 years of age with a BMI<30, with no history of cardiovascular disease Patients: Medically stable, male or female ≥ 18 years of age diagnosed with an atherosclerotic plaque in the carotid artery who have not undergone stenting of the carotid artery to be imaged. Ability to read and understand informed consent Exclusion Criteria: Contraindications to MRI including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy. Inability to tolerate MRI secondary to an inability to lie supine or severe claustrophobia. Non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions Severe allergy to animal dander or animal-instigated asthma Specific to gadolinium-based contrast agents: Renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR <45ml/min) or previous allergic reaction to gadolinium-based contrast agents.*

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>100 healthy volunteers will take MRI with/without contrast using both conventional protocol and our developed protocol. Image quality and image contrast will be compared between the two protocols. | Other: MRI with/without contrast<br>* Bilateral carotid plaque imaging at 3.0T. Conventional MRI scans with T1-, T2-weightings and scans using the developed techniques. MR contrast may be used in conventional protocol when it is needed to evaluate the performance of the developed techniques<br>|
| Patients with Carotid Artery Disease<br>40 patients will take MRI with/without contrast using both conventional protocol and our developed protocol. Image quality, image contrast, and composition analysis will be compared between the protocols. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality score | Images collected from both investigational MRI pulse sequences and conventional protocol will be reviewed and scored by readers and compared. | Within one year of scans | 
| Adverse plaque characteristics detection | In patient study, the analysis of adverse plaque characteristics will be performed and compared between the conventional protocol and developed protocol. | Within one year of scans | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image contrast-to-noise ratio | Contrast-to-noise ratio will be measured on the images collected with the conventional protocol and developed protocol and compared. | Within one year of scans | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Plaque Characterization