3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery

Completed

• Conditions: Carotid Artery Disease
• Interventions: Other: MRI with/without contrast

• Registration Number: NCT02163408
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-13
• Study Start: 2014-06-24
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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.*

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	MRI with/without contrast	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Image contrast-to-noise ratio	Within one year of scans	Contrast-to-noise ratio will be measured on the images collected with the conventional protocol and developed protocol and compared.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States