Stroke Clinical Trial
— BioImage2Official title:
BioImage 2: Long-Term Follow-up of BioImage Study Cohort to Investigate Natural History of Carotid Plaque as Determined by 3D Ultrasound
Verified date | October 2017 |
Source | BioImage-2 LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 1000 |
Est. completion date | October 22, 2023 |
Est. primary completion date | September 22, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Weight > 350 pounds - Inability to comply with the visit to the study clinic and other study requirements |
Country | Name | City | State |
---|---|---|---|
United States | Chen Senior Medical Center - Lauderhill | Lauderhill | Florida |
Lead Sponsor | Collaborator |
---|---|
Pieter Muntendam | AstraZeneca, Icahn School of Medicine at Mount Sinai |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum in: JACC Cardiovasc Imaging. 2013 Jan;6(1):131-2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To investigate natural history of subclinical atherosclerosis as determined by 3D carotid ultrasound. | 5 Years | ||
Primary | To evaluate the role of risk factors in disease progression of subclinical atherosclerosis. | 5 Years | ||
Secondary | To assess persistence of risk factors over an approximately 5-year time span between the baseline and the planned follow-up evaluation. | 5 Years |
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