| The BioImage Study: novel approaches to risk assessment in the primary prevention of atherosclerotic cardiovascular disease--study design and objectives. | |
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MedLine Citation:
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PMID: 20598972 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The identification of asymptomatic individuals at risk for near-term atherothrombotic events to ensure optimal preventive treatment remains a challenging goal. In the BioImage Study, novel approaches are tested in a typical health-plan population. Based on certain demographic and risk characteristics on file with Humana Inc, a total of 7,687 men 55 to 80 years of age and women 60 to 80 years of age without evidence of atherothrombotic disease but presumed to be at risk for near-term atherothrombotic events were enrolled between January 2008 and June 2009. Those who met the prespecified eligibility criteria were randomized to a telephonic health survey only (survey only: n = 865), standard risk assessment (Framingham only: n = 718), or comprehensive risk assessment in a dedicated mobile facility equipped with advanced imaging tools (n = 6,104). Baseline examination included assessment of cardiovascular risk factors and screening for subclinical (asymptomatic) atherosclerosis with quantification of coronary artery calcification by computed tomography (CT), measurement of intima-media thickness, presence of carotid atherosclerotic plaques and abdominal aortic aneurysm by ultrasound, and ankle brachial index. Participants with one or more abnormal screening test results underwent advanced imaging with contrast-enhanced magnetic resonance imaging for carotid and aortic plaques, contrast-enhanced coronary CT angiography for luminal stenosis and noncalcified plaques, and 18F-fluorodeoxyglucose-positron emission tomography/CT for carotid and aortic plaque inflammation. Plasma, PAXgene RNA, and DNA samples were obtained, frozen, and stored for future biomarker discovery studies. All individuals will be followed until 600 major atherothrombotic events have occurred in those undergoing imaging. The BioImage Study will help identify those patients with subclinical atherosclerosis who are at risk for near-term atherothrombotic events and enable a more personalized management of care. |
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Authors:
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Pieter Muntendam; Carol McCall; Javier Sanz; Erling Falk; Valentin Fuster; |
Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: American heart journal Volume: 160 ISSN: 1097-6744 ISO Abbreviation: Am. Heart J. Publication Date: 2010 Jul |
Date Detail:
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Created Date: 2010-07-05 Completed Date: 2010-08-17 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0370465 Medline TA: Am Heart J Country: United States |
Other Details:
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Languages: eng Pagination: 49-57.e1 Citation Subset: AIM; IM |
Copyright Information:
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Copyright (c) 2010 Mosby, Inc. All rights reserved. |
Affiliation:
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BG Medicine Inc, Waltham, MA, USA. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00738725 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Aged, 80 and over Atherosclerosis / complications, diagnosis*, epidemiology Biological Markers / blood Coronary Angiography / methods* Cross-Sectional Studies Female Follow-Up Studies Humans Incidence Male Middle Aged Myocardial Infarction / epidemiology, etiology, prevention & control* Primary Prevention / methods* Prognosis Prospective Studies Risk Assessment / methods* Stroke / epidemiology, etiology, prevention & control* Tomography, Emission-Computed, Single-Photon / methods* Tomography, X-Ray Computed United States |
| Chemical | |
Reg. No./Substance:
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0/Biological Markers |
| Investigator | |
Investigator/Affiliation:
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Valentin Fuster / ; Erling Falk / ; Juan José Badimon / ; René M Botnar / ; Mat J A P Daemen / ; Zahi A Fayad / ; Mario Garcia / ; Geoffrey S Ginsburg / ; Stanley L Hazen / ; Spencer B King / ; Pedro R Moreno / ; Børge G Nordestgaard / ; James H F Rudd / ; Predimon K Shah / ; Henrik Sillesen / ; Antonius F W Van der Steen / ; Magdi H Yacoub / ; Chun Yuan / ; James T Bui / ; Christopher J Chen / ; Albert Seow / ; Pieter Muntendam / ; Andrew Plump / ; Joel Raichlen / ; Paul Smit / ; James C Stolzenbach / ; Richard Urquhart / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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