Natural History of Carotid Plaque as Determined by 3D Ultrasound
NCT ID: NCT03314818
Last Updated: 2017-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1000 participants
OBSERVATIONAL
2017-09-22
2023-10-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
One of the striking novel findings in the BioImage study was the prevalence of subclinical atherosclerotic disease in the carotid arteries as determined by a novel 3D ultrasound method. 3D carotid imaging was used to identify lesions located in the cervical part of the common carotid arteries (CCA) and internal carotid artery. 3D carotid imaging was initially performed using a high- resolution, linear array 2-dimensional transducer and scanning the artery in cross-section, slowly moving the transducer manually in the cranial direction from the proximal CCA into the distal internal carotid artery (i.e., from the clavicle to jawbone). The resulting 10-s digital video clip of this "manual 3D" cross-sectional sweep was examined in the core ultrasound laboratory for the presence and quantification of plaque. In the second phase of the study an electromechanical transducer was used to accomplish a similar sweep, replacing the manual sweep with a controlled movement of the transducer.
This ultrasound technique identified carotid plaques in 78% of cases. Carotid plaque burden was found to correlate stronger with CACS (chi-square 450, p \< 0.0001) than did cIMT (chi-square 24, p \< 0.0001)15. Analyses have indicated that subclinical atherosclerosis as determined by 3D ultrasound is an important risk factor with marked incremental value over conventional risk-factor based scores such as the Framingham Risk Score.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ultrasound 3D Imaging
To investigate natural history of subclinical atherosclerosis as determined by 3D carotid ultrasound.
Ultrasound 3D Imaging
Carotid artery ultrasound will be used to:
Determine plaque presence and plaque burden Presence of stenosis
Additionally, Carotid Intima-Media Thickness (IMT) will be measured and aortic diameter will be measured by abdominal aortic ultrasound scanning.
Ultrasound of the Abdominal Aorta will be used to determine the presence and severity of stenosis or aneurism.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ultrasound 3D Imaging
Carotid artery ultrasound will be used to:
Determine plaque presence and plaque burden Presence of stenosis
Additionally, Carotid Intima-Media Thickness (IMT) will be measured and aortic diameter will be measured by abdominal aortic ultrasound scanning.
Ultrasound of the Abdominal Aorta will be used to determine the presence and severity of stenosis or aneurism.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to travel to the location where the mobile research unit will be located (various locations in the Chicago area or Fort Lauderdale, Florida area)
* Written informed consent must be obtained before any assessment is performed
Exclusion Criteria
* Inability to comply with the visit to the study clinic and other study requirements
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Icahn School of Medicine at Mount Sinai
OTHER
AstraZeneca
INDUSTRY
Pieter Muntendam
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pieter Muntendam
Overall Co-Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Valentin Fuster, M.D.
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Pieter Muntendam, M.D.
Role: PRINCIPAL_INVESTIGATOR
BioImage-2 LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chen Senior Medical Center - Lauderhill
Lauderhill, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Muntendam P, McCall C, Sanz J, Falk E, Fuster V; High-Risk Plaque Initiative. The BioImage Study: novel approaches to risk assessment in the primary prevention of atherosclerotic cardiovascular disease--study design and objectives. Am Heart J. 2010 Jul;160(1):49-57.e1. doi: 10.1016/j.ahj.2010.02.021.
Sillesen H, Muntendam P, Adourian A, Entrekin R, Garcia M, Falk E, Fuster V. Carotid plaque burden as a measure of subclinical atherosclerosis: comparison with other tests for subclinical arterial disease in the High Risk Plaque BioImage study. JACC Cardiovasc Imaging. 2012 Jul;5(7):681-9. doi: 10.1016/j.jcmg.2012.03.013.
Baber U, Mehran R, Sartori S, Schoos MM, Sillesen H, Muntendam P, Garcia MJ, Gregson J, Pocock S, Falk E, Fuster V. Prevalence, impact, and predictive value of detecting subclinical coronary and carotid atherosclerosis in asymptomatic adults: the BioImage study. J Am Coll Cardiol. 2015 Mar 24;65(11):1065-74. doi: 10.1016/j.jacc.2015.01.017.
Natarajan P, Kohli P, Baber U, Nguyen KH, Sartori S, Reilly DF, Mehran R, Muntendam P, Fuster V, Rader DJ, Kathiresan S. Association of APOC3 Loss-of-Function Mutations With Plasma Lipids and Subclinical Atherosclerosis: The Multi-Ethnic BioImage Study. J Am Coll Cardiol. 2015 Nov 3;66(18):2053-2055. doi: 10.1016/j.jacc.2015.08.866. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HRP-002
Identifier Type: -
Identifier Source: org_study_id