Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:5/27/2013
Start Date:November 2012
End Date:April 2013
Contact:Josh Sugino
Email:jsugino@mimg.com
Phone:949-364-6000

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Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors (Cardiac-CV)


The objective of this study is to explore the relationship between the ClearView scan
results and a variety of cardiovascular risk indicators such as the Coronary Calcium Score,
Framingham Risk Factors, Reynolds Risk Score, and biomarkers of inflammation. The ClearView
device is a bio-electrographic tool that may assist medical professionals in rapid
assessment of the systemic origin of the patient's presenting symptom(s). The ClearView is a
potentially valuable resource that may benefit a physician's office by offering expedited
differentiation capabilities. The subsequent results have the potential to include more
data that would allow rapid patient diagnosis, triage, and treatment; optimized precious
resource expenditure (nursing, physician, etc.); lower costs to facility, patient and
insurance company; and decreased office wait time.


Inclusion Criteria:

- Sex: Male or Female

- Age range: 18 to 85

- Patients who are recommended for and who have had a cardiac CT study that produces a
Coronary Calcium Score within 30 days prior to the ClearView Scan or plan to have the
CT within 14 days after the ClearView Scan.

- Patients who have had a blood test resulting in hs-CRP, fasting lipid panel and MPO
results within 6 months prior to the ClearView Scan or plan to have the tests done
within 14 days after the ClearView Scan.

- The patient or legal representative is able to understand and provide signed consent
for the procedure.

Exclusion Criteria:

- Patients with pacemakers or another implanted electrical device, such as an automatic
internal cardiac defibrillator.

- Patients connected to an electrical device that cannot be removed or temporarily
powered off (i.e. monitor) during subject testing with the ClearView Device

- Vulnerable populations

- Patients actively being treated for cancer or with a previous diagnosis of
cancer that required chemotherapy, radiation therapy or hormonal therapy.

- Patients missing all or any part of a fingertip (excluding fingernail).

- Patients with involuntary hand tremors /shaking of the hands that may prevent
clear imaging.
We found this trial at
1
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Mission Viejo, California 92691
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Mission Viejo, CA
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