PlaqueNCT00738725
BioImage Study: A Clinical Study of Burden of Atherosclerotic Disease in an At-Risk Population
An observational study of Plaque and Atherosclerotic Disease, run by BG Medicine, Inc at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Atherosclerotic Disease, Heart Disease
- How many people
- 7,687 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Males Age: 55-80 years old;
- Females Age: 60-80 years old;
- Current Humana plan member;
- Resident in Chicago, Louisville, or South Florida
Who cannot join
- 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;
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- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Forest Med-Surg Center
Justice, Illinois, 60458
North Ridge Medical Center
Oakland Park, Florida, 33334
About this study
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
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.
- Conditions
- Plaque, Atherosclerotic Disease, Heart Disease, Stroke
- Keywords
- High risk plaque, High-risk plaque, Vulnerable plaque, Atherosclerotic Disease, Heart Disease, Stroke
- Medical subject headings
- Plaque, Amyloid, Heart Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Survey only | |
| 2 | Imaging group | |
| 3 | Non-imaging group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-years or when 600 events have been observed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,687 participants (actual)
Sponsor and investigators
- Lead sponsor
- BG Medicine, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca, Abbott, Merck Sharp & Dohme LLC, Philips Medical Systems, Takeda
- Responsible party
- Sponsor
- Investigators
- Valentin Fuster, MD, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiErling Falk, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738725
- Sponsor's protocol ID
- HRP-001
- Status last verified
- Oct 2013
- First submitted
- 19 Aug 2008
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Natarajan P, Young R, Stitziel NO, Padmanabhan S, Baber U, Mehran R, Sartori S, Fuster V, Reilly DF, Butterworth A, Rader DJ, Ford I, Sattar N, Kathiresan S. Polygenic Risk Score Identifies Subgroup With Higher Burden of Atherosclerosis and Greater Relative Benefit From Statin Therapy in the Primary Prevention Setting. Circulation. 2017 May 30;135(22):2091-2101. doi: 10.1161/CIRCULATIONAHA.116.024436. Epub 2017 Feb 21.
PubMed 28223407Natarajan P, Kohli P, Baber U, Nguyen KH, Sartori S, Reilly DF, Mehran R, Muntendam P, Fuster V, Rader DJ, Kathiresan S. Association of APOC3 Loss-of-Function Mutations With Plasma Lipids and Subclinical Atherosclerosis: The Multi-Ethnic BioImage Study. J Am Coll Cardiol. 2015 Nov 3;66(18):2053-2055. doi: 10.1016/j.jacc.2015.08.866. No abstract available.
PubMed 26516010Baber U, Mehran R, Sartori S, Schoos MM, Sillesen H, Muntendam P, Garcia MJ, Gregson J, Pocock S, Falk E, Fuster V. Prevalence, impact, and predictive value of detecting subclinical coronary and carotid atherosclerosis in asymptomatic adults: the BioImage study. J Am Coll Cardiol. 2015 Mar 24;65(11):1065-74. doi: 10.1016/j.jacc.2015.01.017.
PubMed 25790876Sillesen H, Muntendam P, Adourian A, Entrekin R, Garcia M, Falk E, Fuster V. Carotid plaque burden as a measure of subclinical atherosclerosis: comparison with other tests for subclinical arterial disease in the High Risk Plaque BioImage study. JACC Cardiovasc Imaging. 2012 Jul;5(7):681-9. doi: 10.1016/j.jcmg.2012.03.013.
PubMed 22789936Muntendam P, McCall C, Sanz J, Falk E, Fuster V; High-Risk Plaque Initiative. The BioImage Study: novel approaches to risk assessment in the primary prevention of atherosclerotic cardiovascular disease--study design and objectives. Am Heart J. 2010 Jul;160(1):49-57.e1. doi: 10.1016/j.ahj.2010.02.021.
PubMed 20598972
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00738725
- Acronym / sponsor ID
- HRP-001
- Conditions
- Plaque, Atherosclerotic Disease, Heart Disease, Stroke
- Keywords
- High risk plaque, High-risk plaque, Vulnerable plaque, Atherosclerotic Disease, Heart Disease, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,687 participants (actual)
- Lead sponsor
- BG Medicine, IncIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca, Abbott, Merck Sharp & Dohme LLC, Philips Medical Systems, Takeda
- Study start
- Jan 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Survey only |
| 2 | – | –Imaging group |
| 3 | – | –Non-imaging group |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Males Age: 55-80 years old;
- Females Age: 60-80 years old;
- Current Humana plan member;
- Resident in Chicago, Louisville, or South Florida
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Derived from this study: PubMed 28223407Natarajan P, Young R, Stitziel NO, Padmanabhan S, Baber U, Mehran R, Sartori S, Fuster V, Reilly DF, Butterworth A, Rader DJ, Ford I, Sattar N, Kathiresan S. Polygenic Risk Score Identifies Subgroup With Higher Burden of Atherosclerosis and Greater Relative Benefit From Statin Therapy in the Primary Prevention Setting. Circulation. 2017 May 30;135(22):2091-2101. doi: 10.1161/CIRCULATIONAHA.116.024436. Epub 2017 Feb 21.
- Derived from this study: PubMed 26516010Natarajan P, Kohli P, Baber U, Nguyen KH, Sartori S, Reilly DF, Mehran R, Muntendam P, Fuster V, Rader DJ, Kathiresan S. Association of APOC3 Loss-of-Function Mutations With Plasma Lipids and Subclinical Atherosclerosis: The Multi-Ethnic BioImage Study. J Am Coll Cardiol. 2015 Nov 3;66(18):2053-2055. doi: 10.1016/j.jacc.2015.08.866. No abstract available.
- Derived from this study: PubMed 25790876Baber U, Mehran R, Sartori S, Schoos MM, Sillesen H, Muntendam P, Garcia MJ, Gregson J, Pocock S, Falk E, Fuster V. Prevalence, impact, and predictive value of detecting subclinical coronary and carotid atherosclerosis in asymptomatic adults: the BioImage study. J Am Coll Cardiol. 2015 Mar 24;65(11):1065-74. doi: 10.1016/j.jacc.2015.01.017.
- Derived from this study: PubMed 22789936Sillesen H, Muntendam P, Adourian A, Entrekin R, Garcia M, Falk E, Fuster V. Carotid plaque burden as a measure of subclinical atherosclerosis: comparison with other tests for subclinical arterial disease in the High Risk Plaque BioImage study. JACC Cardiovasc Imaging. 2012 Jul;5(7):681-9. doi: 10.1016/j.jcmg.2012.03.013.
- Derived from this study: PubMed 20598972Muntendam P, McCall C, Sanz J, Falk E, Fuster V; High-Risk Plaque Initiative. The BioImage Study: novel approaches to risk assessment in the primary prevention of atherosclerotic cardiovascular disease--study design and objectives. Am Heart J. 2010 Jul;160(1):49-57.e1. doi: 10.1016/j.ahj.2010.02.021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentin Fuster, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Erling Falk, MD, PhD principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque and Atherosclerotic Disease, run by BG Medicine, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738725, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.