Natural History of Carotid Plaque as Determined by 3D Ultrasound
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2017 |
| Start Date: | September 22, 2017 |
| End Date: | October 22, 2023 |
BioImage 2: Long-Term Follow-up of BioImage Study Cohort to Investigate Natural History of Carotid Plaque as Determined by 3D Ultrasound
This proposed follow-up study aims to recruit participants from the original BioImage cohort
for a one-time follow-up examination. The repeat ultrasound scan of the carotid arteries will
provide information on the natural history of carotid atherosclerosis and factors that
contribute to plaque progression. Renewal of the HIPAA authorization will also be sought for
5 years to continue to monitor claims and other information for major cardiovascular events,
other outcomes and healthcare utilization.
for a one-time follow-up examination. The repeat ultrasound scan of the carotid arteries will
provide information on the natural history of carotid atherosclerosis and factors that
contribute to plaque progression. Renewal of the HIPAA authorization will also be sought for
5 years to continue to monitor claims and other information for major cardiovascular events,
other outcomes and healthcare utilization.
The design and objectives of the BioImage study (NCT00738725) have been published in detail.
In brief, the BioImage study is investigating whether imaging of target arteries for
subclinical atherosclerosis and measurement of ABI and circulating biomarkers add to the
predictive value of traditional risk factor scoring systems, namely, the Framingham Risk
Score. Enrollment in the BioImage study (January 2008 to June 2009) resulted in inclusion of
7,687 asymptomatic Americans ages 55 to 80 years from the Humana Health System resident in
Chicago, Illinois, or Fort Lauderdale, Florida. Of these, 6,104 entered the imaging arm of
the study. Analysis of the BioImage study cross- sectional baseline findings has yielded
important novel findings related to presence and severity of subclinical atherosclerosis and
the role of markers of subclinical disease to identify those at elevated risk for near-term
atherothrombotic events.
One of the striking novel findings in the BioImage study was the prevalence of subclinical
atherosclerotic disease in the carotid arteries as determined by a novel 3D ultrasound
method. 3D carotid imaging was used to identify lesions located in the cervical part of the
common carotid arteries (CCA) and internal carotid artery. 3D carotid imaging was initially
performed using a high- resolution, linear array 2-dimensional transducer and scanning the
artery in cross-section, slowly moving the transducer manually in the cranial direction from
the proximal CCA into the distal internal carotid artery (i.e., from the clavicle to
jawbone). The resulting 10-s digital video clip of this "manual 3D" cross-sectional sweep was
examined in the core ultrasound laboratory for the presence and quantification of plaque. In
the second phase of the study an electromechanical transducer was used to accomplish a
similar sweep, replacing the manual sweep with a controlled movement of the transducer.
This ultrasound technique identified carotid plaques in 78% of cases. Carotid plaque burden
was found to correlate stronger with CACS (chi-square 450, p < 0.0001) than did cIMT
(chi-square 24, p < 0.0001)15. Analyses have indicated that subclinical atherosclerosis as
determined by 3D ultrasound is an important risk factor with marked incremental value over
conventional risk-factor based scores such as the Framingham Risk Score.
In brief, the BioImage study is investigating whether imaging of target arteries for
subclinical atherosclerosis and measurement of ABI and circulating biomarkers add to the
predictive value of traditional risk factor scoring systems, namely, the Framingham Risk
Score. Enrollment in the BioImage study (January 2008 to June 2009) resulted in inclusion of
7,687 asymptomatic Americans ages 55 to 80 years from the Humana Health System resident in
Chicago, Illinois, or Fort Lauderdale, Florida. Of these, 6,104 entered the imaging arm of
the study. Analysis of the BioImage study cross- sectional baseline findings has yielded
important novel findings related to presence and severity of subclinical atherosclerosis and
the role of markers of subclinical disease to identify those at elevated risk for near-term
atherothrombotic events.
One of the striking novel findings in the BioImage study was the prevalence of subclinical
atherosclerotic disease in the carotid arteries as determined by a novel 3D ultrasound
method. 3D carotid imaging was used to identify lesions located in the cervical part of the
common carotid arteries (CCA) and internal carotid artery. 3D carotid imaging was initially
performed using a high- resolution, linear array 2-dimensional transducer and scanning the
artery in cross-section, slowly moving the transducer manually in the cranial direction from
the proximal CCA into the distal internal carotid artery (i.e., from the clavicle to
jawbone). The resulting 10-s digital video clip of this "manual 3D" cross-sectional sweep was
examined in the core ultrasound laboratory for the presence and quantification of plaque. In
the second phase of the study an electromechanical transducer was used to accomplish a
similar sweep, replacing the manual sweep with a controlled movement of the transducer.
This ultrasound technique identified carotid plaques in 78% of cases. Carotid plaque burden
was found to correlate stronger with CACS (chi-square 450, p < 0.0001) than did cIMT
(chi-square 24, p < 0.0001)15. Analyses have indicated that subclinical atherosclerosis as
determined by 3D ultrasound is an important risk factor with marked incremental value over
conventional risk-factor based scores such as the Framingham Risk Score.
Inclusion Criteria:
- Participant in BioImage Study cohort with successful completion of carotid ultrasound
imaging investigation
- Ability to travel to the location where the mobile research unit will be located
(various locations in the Chicago area or Fort Lauderdale, Florida area)
- Written informed consent must be obtained before any assessment is performed
Exclusion Criteria:
- Weight > 350 pounds
- Inability to comply with the visit to the study clinic and other study requirements
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