Skip to main content
OpenTrials
Completed

NCT Number: NCT02163408

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.*

Treatment and study plan

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

Primary outcomes

  1. Image quality score

    Time frame: 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

    Time frame: 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 outcomes

  1. Image contrast-to-noise ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • American Heart Association
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2014
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.