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BioImage Study: A Clinical Study of Burden of Atherosclerotic Disease in an At-Risk Population

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
AstraZeneca
Abbott
Merck Sharp & Dohme Corp.
Philips Medical Systems
Takeda
Information provided by (Responsible Party):
BG Medicine, Inc
ClinicalTrials.gov Identifier:
NCT00738725
First received: August 19, 2008
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition
Plaque
Atherosclerotic Disease
Heart Disease
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by BG Medicine, Inc:

Primary Outcome Measures:
  • 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 [ Time Frame: 3-years or when 600 events have been observed ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, plasma, RNA and DNA


Estimated Enrollment: 7300
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Survey only
2
Imaging group
3
Non-imaging group

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Recruitment will be limited to the Humana membership base using health insurance claims information to identify potential study candidates. Candidate selection algorithms have been developed to identify members who have no prior history of cardiovascular disease, but most likely would be at intermediate to high risk for atherosclerotic cardiovascular events. The target is to recruit a population that has similar demographics to the US population in terms of race and ethnicity.

The participant selection criteria for the Humana database extraction to represent a medium to high risk population*: current Humana member with at least 3 months continuous enrollment; resides in one of the three study markets; pharmacy or medical claim for diabetes, hypertension, obesity or abnormal lipid.

*Note: A separate selection will be for patients without any pharmacy claims to represent 20% of the study population.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738725

Locations
United States, Florida
North Ridge Medical Center
Oakland Park, Florida, United States, 33334
United States, Illinois
Forest Med-Surg Center
Justice, Illinois, United States, 60458
Sponsors and Collaborators
BG Medicine, Inc
AstraZeneca
Abbott
Merck Sharp & Dohme Corp.
Philips Medical Systems
Takeda
Investigators
Principal Investigator: Valentin Fuster, MD, PhD Mount Sinai School of Medicine
Principal Investigator: Erling Falk, MD, PhD Aarhus University Hospital
  More Information

No publications provided by BG Medicine, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BG Medicine, Inc
ClinicalTrials.gov Identifier: NCT00738725     History of Changes
Other Study ID Numbers: HRP-001
Study First Received: August 19, 2008
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by BG Medicine, Inc:
High risk plaque
High-risk plaque
Vulnerable plaque
Atherosclerotic Disease
Heart Disease
Stroke

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014