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

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.

Study Overview

• Status: Suspended
• Conditions: Cardiovascular Diseases; Coronary Artery Disease

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States, 92691
      • Mission Internal Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of ClearView scan with cardiovascular risk indicators	Statistical agreement will be assessed between the ClearView Response result and the results of the Corinary Calcium Score, Inflammatory biomarkers, lipid panel results and cardiovascular risk indicators as reported by the medical exam, on a per-subject basis.	Single Study Vist, no follow-up.

Collaborators and Investigators

• Sponsor: Epic Research & Diagnostics, Inc.
• Collaborators: Mission Internal Medical Group
• Investigators: Principal Investigator: Michael Miyamoto, MD, Mission Internal Medical Group

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Estimate): June 14, 2013
• Last Update Submitted That Met QC Criteria: June 13, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Health Risk Appraisal; HCardiac Risk Factors
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Cardiovascular Diseases
• Other Study ID Numbers: EPIC-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No