Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors

NCT ID: NCT01740739

Last Updated: 2013-06-14

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-06-30

Brief Summary

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.

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cardiac Risk

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mission Internal Medical Group

UNKNOWN

Sponsor Role: collaborator

Epic Research & Diagnostics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Miyamoto, MD

Role: PRINCIPAL_INVESTIGATOR

Mission Internal Medical Group

Locations

Mission Internal Medical Group

Mission Viejo, California, United States

Countries

United States

Other Identifiers

EPIC-006

Identifier Type: -

Identifier Source: org_study_id