Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors

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Conditions studied: Cardiovascular Diseases, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01740739

Run by

Epic Research & Diagnostics, Inc.

People needed

60

Starts

2012-11-01

Expected to finish

2013-06-01

Last updated by the study team

2013-06-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mission Internal Medical Group — Mission Viejo, California, United States

Full record on ClinicalTrials.gov

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