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3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery

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ClinicalTrials.gov Identifier: NCT02163408
Recruitment Status : Recruiting
First Posted : June 13, 2014
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Heart Association
Information provided by (Responsible Party):
Debiao Li, PhD, Cedars-Sinai Medical Center

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
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.

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery
Actual Study Start Date : June 24, 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.*

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163408


Contacts
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Contact: Johanna Kim, MPH 310 248-8680 johanna.kim@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Sub-Investigator: Zhaoyang Fan, PhD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
American Heart Association
Investigators
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Principal Investigator: Debiao Li, PhD Cedars-Sinai Medical Center

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Responsible Party: Debiao Li, PhD, Director, Biomedical Imaging Research Institute, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02163408     History of Changes
Other Study ID Numbers: 35762
2R01HL096119-05 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Keywords provided by Debiao Li, PhD, Cedars-Sinai Medical Center:
MRI
Plaque Characterization
Additional relevant MeSH terms:
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Carotid Artery Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases