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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740739
Recruitment Status : Suspended (Evaluating cohort for value)
First Posted : December 4, 2012
Last Update Posted : June 14, 2013
Sponsor:
Collaborator:
Mission Internal Medical Group
Information provided by (Responsible Party):
Epic Research & Diagnostics, Inc.

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.

Condition or disease
Cardiovascular Diseases Coronary Artery Disease

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors (Cardiac-CV)
Study Start Date : November 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

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.



Primary Outcome Measures :
  1. Association of ClearView scan with cardiovascular risk indicators [ Time Frame: Single Study Vist, no follow-up. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740739


Locations
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United States, California
Mission Internal Medical Group
Mission Viejo, California, United States, 92691
Sponsors and Collaborators
Epic Research & Diagnostics, Inc.
Mission Internal Medical Group
Investigators
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Principal Investigator: Michael Miyamoto, MD Mission Internal Medical Group
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Responsible Party: Epic Research & Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01740739    
Other Study ID Numbers: EPIC-006
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: June 14, 2013
Last Verified: June 2013
Keywords provided by Epic Research & Diagnostics, Inc.:
Health Risk Appraisal
HCardiac Risk Factors
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases