3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery

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.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Disease
• Intervention / Treatment: Other: MRI with/without contrast

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 Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

100 healthy volunteers and 40 patients with carotid artery disease will be recruited for this technical development study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; 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; 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
Patients with Carotid Artery Disease; 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?

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); American Heart Association
• Investigators: Principal Investigator: Debiao Li, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2014
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): April 25, 2022

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimated): June 13, 2014

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Plaque Characterization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Artery Diseases; Atherosclerosis
• Other Study ID Numbers: 35762; 2R01HL096119-05 (U.S. NIH Grant/Contract)