BioImage Study

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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 has recently completed the enrollment of 6,822 participants using a novel and exciting approach for conducting critical medical research. The BioImage Study brought the study to the people, rather than using only academic research centers and the patients with access to these centers. This novel approach has allowed 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 made it logistically convenient for the participants, while at the same time improving the quality of the research being conducted. Volunteers were recruited from among Humana health benefit plan members. The involvement of the volunteer’s health plan allowed for a better integration between a volunteer’s research participation and the health care they receive.

The study was conducted at sites near Chicago (Illinois) and Fort Lauderdale (Florida). Study enrollment started in Chicago in the first quarter of 2008 and concluded in Florida on June 30, 2009.

Here are some important facts about the study¹:

• Enrollment:
  • 6,822 female and male volunteers
• Eligibility:
  • Age: 60-80 for females; 55-80 for males
  • Race: racial and ethnic diversity representative of US population
  • 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 computed tomography (CT) and ultrasound of carotid arteries and aorta (6,100 of the 6,800 volunteers)
  • For individuals who were found to be at high risk, based on the initial studies:
    • CT Angiogram – CT study to inspect the coronary vessels (380 volunteers)
    • Magnetic Resonance Imaging (with or without contrast) – MRI study of carotid arteries and aorta (525 volunteers)
    • Positron-Emission Tomography (PET) - PET/CT study of carotid arteries and aorta (177 volunteers)
• Follow-up:
  • Periodic assessment of Humana medical and pharmacy claims data, together with mortality data, for at least 3 years or until ~600 atherothrombotic events are identified

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

¹ This is an abbreviated description of the study design and list of the study procedures – the study protocol and informed consent documents provide full details of procedures, risk and benefits. procedures, risk and benefits.