BioImage2
BioImage 2: Long-Term Follow-up of BioImage Study Cohort to Investigate Natural History of Carotid Plaque as Determined by 3D Ultrasound
Sponsor study identifier
observational
1,000
1 country
1
Study Start
September 22, 2017
Actual (reported)Primary Completion
September 22, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2017
Actual (reported)October 16, 2017
Actual (reported)October 19, 2017
Actual (reported)September 22, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
To assess persistence of risk factors over an approximately 5-year time span between the baseline and the planned follow-up evaluation.
5 Years
To investigate natural history of subclinical atherosclerosis as determined by 3D carotid ultrasound.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Chen Senior Medical Center - Lauderhill
Lauderhill, Florida, 33313, United States
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.
Valentin Fuster, M.D.
Icahn School of Medicine at Mount Sinai
Pieter Muntendam, M.D.
BioImage-2 LLC
First Submitted
October 16, 2017
First Posted
October 19, 2017
Study Start
September 22, 2017
Actual (reported)Primary Completion
September 22, 2018
Estimated (date passed)Women's Assessed Cardiovascular Evaluation With MCG
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 19, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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