3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery

Carotid Artery Disease Clinical Trial

Official title:

3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163408
• Other study ID #: 35762
• Secondary ID: 2R01HL096119-05
• Status: Completed
• Start date: June 24, 2014
• Est. completion date: April 25, 2022

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.*

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Disease
• Carotid Artery Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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