3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02163408
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), American Heart Association (Other)
• Enrollment: 140
• Location: 1
• Anticipated Duration (Months): 95.2
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Disease	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 Design

• Study Type: Observational
• Anticipated Enrollment: 140 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery
• Actual Study Start Date: Jun 24, 2014
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.*

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center
• National Heart, Lung, and Blood Institute (NHLBI)
• American Heart Association

Investigators

• Principal Investigator: Debiao Li, PhD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Debiao Li, PhD, Director, Biomedical Imaging Research Institute, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT02163408
• Other Study ID Numbers: 35762; 2R01HL096119-05
• First Posted: Jun 13, 2014
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Debiao Li, PhD, Director, Biomedical Imaging Research Institute, Cedars-Sinai Medical Center: MRI; Plaque Characterization
• Additional relevant MeSH terms: Carotid Artery Diseases; Atherosclerosis

Study Results

No Results Posted as of Jul 21, 2021