Natural History of Carotid Plaque as Determined by 3D Ultrasound

NCT03314818 | Unknown FDA Device

• 1 other identifier: HRP-002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This proposed follow-up study aims to recruit participants from the original BioImage cohort for a one-time follow-up examination. The repeat ultrasound scan of the carotid arteries will provide information on the natural history of carotid atherosclerosis and factors that contribute to plaque progression. Renewal of the HIPAA authorization will also be sought for 5 years to continue to monitor claims and other information for major cardiovascular events, other outcomes and healthcare utilization.

Conditions

Atherosclerotic Disease; Plaque, Atherosclerotic; Heart Diseases; Stroke; Cardiovascular Risk Factor

Keywords

carotid atherosclerosis; plaque progression; Framingham Risk Score

Outcome Measures

Primary Outcomes (2)

• To investigate natural history of subclinical atherosclerosis as determined by 3D carotid ultrasound.

  5 Years

• To evaluate the role of risk factors in disease progression of subclinical atherosclerosis.

  5 Years

Secondary Outcomes (1)

• To assess persistence of risk factors over an approximately 5-year time span between the baseline and the planned follow-up evaluation.

  5 Years

Study Arms (1)

Ultrasound 3D Imaging

To investigate natural history of subclinical atherosclerosis as determined by 3D carotid ultrasound.

Device: Ultrasound 3D Imaging

Interventions

Ultrasound 3D Imaging DEVICE

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.

Ultrasound 3D Imaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 6,104 participants of the BioImage study were included in the baseline carotid ultrasound investigations. All of the original participants will be evaluated for study inclusion. It is expected that due to death, relocation, admission to nursing homes, disabilities, approximately 3,000 subjects will be available for recruitment for this study. This study aims to re-evaluate the maximum number of participants available with the available resources.

You may qualify if:

• Participant in BioImage Study cohort with successful completion of carotid ultrasound imaging investigation
• 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

You may not qualify if:

• Weight \> 350 pounds
• Inability to comply with the visit to the study clinic and other study requirements

Sponsors & Collaborators

• Pieter Muntendam: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Chen Senior Medical Center - Lauderhill

Lauderhill, Florida, 33313, United States

Location

Related Publications (4)

• 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.

  PMID: 20598972 BACKGROUND

• 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.

  PMID: 22789936 BACKGROUND

• 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.

  PMID: 25790876 BACKGROUND

• 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.

  PMID: 26516010 BACKGROUND

MeSH Terms

Conditions

Plaque, Atherosclerotic; Heart Diseases; Stroke; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Valentin Fuster, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Pieter Muntendam, M.D.

  BioImage-2 LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Overall Co-Principal Investigator

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 19, 2017
• Study Start: September 22, 2017
• Primary Completion: September 22, 2018
• Study Completion: October 22, 2023
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

US (1)