Clinical trial NCT01740739: Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors
Official title: Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors (Cardiac-CV)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Cardiovascular Diseases
Coronary Artery Disease
Keywords: Health Risk Appraisal
HCardiac Risk Factors
Lead sponsor: Epic Research & Diagnostics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mission Internal Medical Group
First posted: 2012-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Association of ClearView scan with cardiovascular risk indicators
timeFrame: Single Study Vist, no follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group
state: California
Study officials:
affiliation: Mission Internal Medical Group
name: Michael Miyamoto, MD
role: PRINCIPAL_INVESTIGATOR
References: