A CDU

This year's annual meeting of the European Society of Cardiology provided the platform for unveiling the High Risk Plaque (HRP) BioImage Study to explore methods for detecting subclinical atherothrombosis disease. The goal of the study is to address earlier management of the disease using new multi-modality hybrid imaging techniques, such as positron emission tomography/computed tomography (PET-CT) and SPECT-CT, which yield fused images of the heart and blood vessels.

The HRP BioImage Study will seek to examine the characteristics of sub-clinical cardiovascular disease, as measured by imaging modalities, circulating biomarker measurements, and risk factors that predict progression to overt clinical cardiovascular disease, in a diverse but population-based sample of 7,300 men (aged 55-80) and women (aged 60-80).

The ESC said that the sociodemographics of the enrollee population will mirror the U.S. population (according to the U.S. Census Bureau's figures for 2000) with about 69% of enrollees to be white, 12% African-American, 13% Hispanic, 4% Asian, predominantly of Chinese descent, and 2% other.

The cohort will be recruited from the Humana Health Plan membership represented in three major U.S. markets: Chicago, Louisville, Kentucky, and Southern Florida.

Of the 7,300 enrollees, 6,000 will be characterized according to their Framingham risk score and various imaging features including carotid and coronary calcification, carotid intimal-medial wall thickness and presence of echogenic lucencies and lower extremity vascular insufficiency as determined by the ankle brachial index.

Blood samples will be assayed for putative biochemical risk factors, using both an unsupervised proteomic and metabolomic profiling of plasma and targeted assays for particular analytes. In addition, samples will be banked for additional follow on studies.

Participants will be followed for identification and characterization of cardiovascular disease events, including acute myocardial infarction and other forms of coronary heart disease (CHD), 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 ESC said the infrastructure and method of recruitment will be "innovative." It will consist of mobile laboratories containing the imaging equipment and will travel to the three markets included in the study. Enrollees will be recruited based on claims monitoring to pre-determine eligibility. The baseline examinations of the participants will occur over a 12- month period.

Based on particular findings, about 2,000 participants of an imaging cohort of 6,000 will be referred for higher resolution imaging modalities to better characterize their arterial disease.

This additional imaging will also be conducted on the mobile laboratories and occur during the same 12-month period.

Participants will be contacted every six months throughout the three-year study to assess cardiovascular events, clinical morbidity and mortality, and to obtain additional blood samples.