Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors

NCT01740739 | Suspended

• 1 other identifier: EPIC-006
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Health Risk Appraisal; HCardiac Risk Factors

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Epic Research & Diagnostics, Inc.: lead
• Mission Internal Medical Group: collaborator

Study Sites (1)

Mission Internal Medical Group

Mission Viejo, California, 92691, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Michael Miyamoto, MD

  Mission Internal Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 14, 2013

Record last verified: 2013-06

Locations

US (1)