3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery

NCT02163408 | Completed

• 2 other identifiers: 357622R01HL096119-05
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Disease

Keywords

MRI; Plaque Characterization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Image contrast-to-noise ratio

  Within one year of scans

Study Arms (2)

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

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.

Interventions

MRI with/without contrast OTHER

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

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.\*

Sponsors & Collaborators

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

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Debiao Li, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Biomedical Imaging Research Institute

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 13, 2014
• Study Start: June 24, 2014
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

US (1)