Cardiovascular DiseasesCardiac-CVNCT01740739
Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors
An observational study of Cardiovascular Diseases and Coronary Artery Disease, run by Epic Research & Diagnostics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Artery Disease
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mission Internal Medical Group
Mission Viejo, California, 92691
About this study
Official title: Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors (Cardiac-CV)
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
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single Study Vist, no follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Evaluating cohort for value
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epic Research & Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mission Internal Medical Group
- Responsible party
- Sponsor
- Investigators
- Michael Miyamoto, MD, Principal investigator, Mission Internal Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740739
- Sponsor's protocol ID
- EPIC-006
- Acronym
- Cardiac-CV
- Status last verified
- Jun 2013
- First submitted
- 16 Nov 2012
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors (Cardiac-CV)
- ClinicalTrials.gov ID
- NCT01740739
- Acronym / sponsor ID
- Cardiac-CV / EPIC-006
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease
- Keywords
- Health Risk Appraisal, HCardiac Risk Factors
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Evaluating cohort for value
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Epic Research & Diagnostics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mission Internal Medical Group
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients with pacemakers or another implanted electrical device, such as an automatic internal cardiac defibrillator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Miyamoto, MD principal investigator
Mission Internal Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Artery Disease, run by Epic Research & Diagnostics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of ClearView scan with cardiovascular risk indicators (time frame: Single Study Vist, no follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.