Ignite Creation Date:
2024-05-05 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00738725
Status:
COMPLETED
Last Update Posted:
2015-01-27
First Post:
2008-08-19
Brief Title:
BioImage Study A Clinical Study of Burden of Atherosclerotic Disease in an At-Risk Population
Sponsor:
BG Medicine Inc
Organization:
BG Medicine Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 7300 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 US 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 7300 participants 6000 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 1300 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 7300 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 3000 participants of the 6000 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
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 7300 participants 6000 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 1300 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 7300 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 3000 participants of the 6000 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None