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

Epic Research & Diagnostics

Status: Suspended

Conditions: Coronary Artery Disease; Cardiovascular Diseases

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01740739

EPIC-006

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

Cardiac Risk

Description:

Patients, as part of their standard of care, who are recommended for and who complete a test resulting in a Coronary Calcium Score, lipid test, hs-CRP and MPO result.