Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors

Coronary Artery Disease Clinical Trial

— Cardiac-CV  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01740739
• Other study ID #: EPIC-006
• Status: Suspended
• Phase: N/A
• First received: November 16, 2012
• Last updated: June 13, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Epic Research & Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Mission Internal Medical Group	Mission Viejo	California

Sponsors (2)

Lead Sponsor	Collaborator
Epic Research & Diagnostics, Inc.	Mission Internal Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No