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SuspendedNCT01740739Cardiac-CVUpdated Jun 14, 2013

Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors

An observational study in Cardiovascular Diseases and Coronary Artery Disease, sponsored by Epic Research & Diagnostics, Inc.. Suspended at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-06-14.

Sponsored by Epic Research & Diagnostics, Inc. · Observational

Why this study was suspended
Evaluating cohort for value
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Cardiovascular Diseases
  • Coronary Artery Disease

Keywords

  • Health Risk Appraisal
  • HCardiac Risk Factors
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 60 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Epic Research & Diagnostics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)

Groups and cohorts

  • 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.

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What researchers measure

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.

    Time frame: Single Study Vist, no follow-up.

07

Study locations

1 site
  • Mission Internal Medical Group
    Mission Viejo, California 92691, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01740739
Lead sponsor
Epic Research & Diagnostics, Inc.
Collaborators
Mission Internal Medical Group
Responsible party
Sponsor
First posted
Dec 4, 2012
Start date
Nov 2012
Primary completion
Jun 2013 (estimated)
Completion
Jun 2013 (estimated)
Last update
Jun 14, 2013

Study contacts

Michael Miyamoto, MD
principal investigator · Mission Internal Medical Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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