BioImage Study

The BioImage Study aims to discover new methods and tests to reliably find people with the highest risk for developing a heart attack or stroke, long before such an event occurs. Early detection can mean early treatment intervention and prevention of heart attacks and strokes for future generations.

The BioImage Study will use a novel and exciting approach for conducting critical medical research. The design of the BioImage Study is such that it brings the study to the people rather than using only academic research centers and the patients with access to these centers. This approach allows us to involve a more diverse population in the Study, representing the average type of individuals who will ultimately benefit from the Study's findings. The study design makes it logistically convenient for the participants while at the same time improving the quality of the research being conducted. Volunteers will be recruited from among Humana health benefit plan members. The involvement of the volunteer’s health plan allows for a better integration between a volunteer’s research participation and the health care they receive. Unfortunately only people who are invited can volunteer for the study.

The sequential study sites are Chicago (Illinois), Louisville (Kentucky) and South Florida. Study enrollment started in Chicago in the first quarter of 2008 and will end in Florida in the first quarter of 2009.

Here are some important facts about the study¹:

• Enrollment:
  • 7,300 female and male volunteers
• Eligibility:
  • Age: 60-80 for females; 55-80 for males
  • Race: study aims to recruit racial and ethnic diversity representative of US
  • No prior major cardiovascular disease
  • No other serious medical condition that can interfere with the study
  • Member of one of the Humana health benefit plans
• Key study procedures at enrollment:
  • Blood samples
  • Physical measurements like blood pressure, height and weight
  • Low dose cardiac CT and Ultrasound (6,000 from 7,300 volunteers)
  • For individuals who are found to be at high risk at the initial studies:
    • CT Angiogram – CT study to inspect the coronary vessels
    • MRI with or without contrast – MRI study of carotids and coronary vessels
• Follow-up:
  • Blood samples and survey every 6 months

The study is done in accordance with all applicable privacy and protection of human subject laws.

¹ This is an abbreviated description of study design and list of study procedures – see protocol and informed consent for procedures, risk and benefits.