BioImage Study: A Clinical Study of Burden of Atherosclerotic Disease in an At-Risk Population
Condition: Plaque; Atherosclerotic Disease; Heart Disease; Stroke
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      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.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study 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.
      
Biospecimen description: 
      Serum, plasma, RNA and DNA
    
Keywords: High risk plaque; High-risk plaque; Vulnerable plaque; Atherosclerotic Disease; Heart Disease; Stroke