Date: 2015-03-26
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the Journal of the American College of Cardiology
Company: BG Medicine (USA - MA) Abbott (USA - IL), AbbVie (USA - IL), AstraZeneca (UK) Merck&Co (USA - NJ) Philips (The Netherlands) Takeda Pharmaceutical (Japan)
Product:
Action mechanism:
Disease:
Therapeutic area: Cardiovascular diseases
Country: USA
Trial
details: 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. (NCT00738725)
Latest
news: * On March 26, 2015, BG Medicine announced the publication of a landmark study, in the Journal of the American College of Cardiology , reporting clinical outcome results of the BioImage Study. The BioImage Study, sponsored by BG Medicine in collaboration with pharmaceutical and healthcare companies Abbott, AbbVie, AstraZeneca, Merck, Philips, and Takeda , is a large, prospective study of cardiovascular disease in asymptomatic men and women in the United States. The BioImage Study recruited 7,687 men and women above the age of 55 and monitored them for approximately 3 years for the occurrence of major cardiovascular events such as heart attack, stroke, and death due to cardiovascular causes. The recent publication appeared in the March 24, 2015 issue of the Journal of the American College of Cardiology. The lead authors, from the Mount Sinai Medical Center in New York , reported the occurrence of 216 first major adverse cardiovascular events in BioImage Study participants during the follow-up period. Of these, the authors found that 184 events, or over 85% of all events, occurred in individuals who were believed at the outset of the study to be at low or intermediate cardiovascular risk, as determined by conventional, office-based Framingham Heart Study risk assessment. The authors report that a significant proportion of men and women, nearly 60%, showed evidence of accumulated plaque in the major arteries that supply blood to the heart and to the brain, indicating potential undetected vascular disease. Participants in the BioImage Study underwent extensive medical imaging to detect such plaques, including experimental ultrasound measurement of the arteries in the neck, and advanced X-ray-based computed tomography scans of the heart.
