Stroke Clinical Trial
Official title:
A Clinical Study of Burden of Atherosclerotic Disease in an At-Risk Population Combining Targeted and Unsupervised Biological Measurements With Non-Invasive Imaging Modalities to Identify Biomarkers That Predict Near Term (1-3-years) Outcomes
Verified date | October 2013 |
Source | BG Medicine, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 7687 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 55 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Males Age: 55-80 years old; - Females Age: 60-80 years old; - Current Humana plan member; - Resident in Chicago, Louisville, or South Florida Exclusion Criteria: - History of Coronary Heart Disease (CHD), including heart attack or angina; - History of cerebrovascular disease (CVD), including stroke; - History of peripheral arterial disease (PAD); - History of or surgery for Abdominal Aortic Aneurysm (AAA); - Having undergone procedures related to cardiovascular disease (CABG, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries); - Heart failure; - Atrial fibrillation; - Active treatment of cancer according to telephone survey response; - Any serious medical condition which would prevent long-term participation or inability to complete the 3-year follow-up (e.g. Dementia, cognitive impairment or Alzheimer's Disease, advanced COPD); - Weight > 350 lbs; - Chest CT scan in the past year; - Cognitive inability as judged by the telephone interviewer; - Language barrier (speaks other than English); - Inability to comply with visit to mobile clinic and other study requirements; - Pregnancy (women > 60 years old are included only) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Forest Med-Surg Center | Justice | Illinois |
United States | North Ridge Medical Center | Oakland Park | Florida |
Lead Sponsor | Collaborator |
---|---|
BG Medicine, Inc | Abbott, AstraZeneca, Merck Sharp & Dohme Corp., Philips Medical Systems, Takeda |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify imaging and/or circulating biomarkers that predict 3-year cardiovascular events with incremental improvement over traditional risk assessment and to determine predictive value of biological and/or imaging markers for near-term (1-3year) outcomes | 3-years or when 600 events have been observed | No |
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