BioImage Study: A Clinical Study of Burden of Atherosclerotic Disease in an At-Risk Population

Completed

Phase N/A Results N/A

Trial Description

The BioImage Study is a study of the characteristics of subclinical cardiovascular disease, as measured by imaging modalities, unsupervised circulating biomarker measurements, and risk factors that predict progression to overt clinical cardiovascular disease, in a diverse, population-based sample of 7,300 men (aged 55-80) and women (aged 60-80). The socio-demographics of the study population aims to mirror the US population as a whole with approximately 69% of the cohort will be white, 12% African-American, 13% Hispanic, 4% Asian, predominantly of Chinese descent and 2% other (U.S. Census Bureau: 2000).
The cohort will be recruited from the Humana Health Plan membership represented in three major US markets; Chicago, Illinois, Louisville, Kentucky and Southern Florida. Of the 7,300 participants, 6,000 will be characterized with respect to their Framingham risk score and various imaging features including coronary calcification, carotid intima-media thickness (IMT), presence of atherosclerotic plaques, and lower extremity vascular insufficiency as determined by the ankle brachial index (ABI). Blood samples will be assayed for putative biomarkers using a variety of methodologies including unsupervised proteomic and metabolomic profiling of plasma, RNA expression profiling and candidate gene analysis or genome wide scanning. These approaches will also be combined with targeted assays for particular analytes. Biological samples will be banked at the time of collection for these analyses and for additional follow on case-control and validation studies. Participants will be followed for identification and characterization of cardiovascular disease events, including acute myocardial infarction and other forms of Coronary Artery Disease (CAD), and stroke; mortality; and for cardiovascular disease interventions. The remaining 1,300 subjects will be evaluated and followed in a similar manner except no imaging studies will be conducted.
The study will be conducted using an innovative infrastructure and method of participant recruitment and enrollment. Mobile clinics containing the imaging equipment will travel to the three markets included in the study. The mobile clinic configuration allows for a high level of consistency in the data measurements which will be collected from diverse geographic areas and populations. Participants will be recruited based on claims monitoring to pre-determine eligibility. The baseline examinations of the 7,300 participants will occur over a 12-month period. Based on particular findings (Coronary Artery Calcium (CAC) score, Carotid Intima-Media Thickness (IMT), atherosclerotic plaque, Ankle Brachial Index (ABI), and presence of Abdominal Aortic Aneurysm (AAA), approximately 3,000 participants of the 6,000 imaging cohort will be referred for higher resolution imaging modalities to better characterize their arterial disease. This additional imaging will also be conducted at the mobile clinics and occur during the same 12-month period. Participants will be contacted every 6-months throughout the 3-year study to assess cardiovascular events, clinical morbidity and mortality, and to obtain additional blood samples.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

Recruitment will be limited to the Humana membership base using health insurance claims information to identify potential study candidates. Candidate selection algorithms have been developed to identify members who have no prior history of cardiovascular disease, but most likely would be at intermediate to high risk for atherosclerotic cardiovascular events. The target is to recruit a population that has similar demographics to the US population in terms of race and ethnicity. The participant selection criteria for the Humana database extraction to represent a medium to high risk population*: current Humana member with at least 3 months continuous enrollment; resides in one of the three study markets; pharmacy or medical claim for diabetes, hypertension, obesity or abnormal lipid. *Note: A separate selection will be for patients without any pharmacy claims to represent 20% of the study population.

Outcomes

Type Measure Time Frame Safety Issue
Primary Identify imaging and/or circulating biomarkers that predict 3-year cardiovascular events with incremental improvement over traditional risk assessment and to determine predictive value of biological and/or imaging markers for near-term (1-3year) outcomes 3-years or when 600 events have been observed No

Biospecimen Retention:Samples With DNA - Serum, plasma, RNA and DNA

Sponsors