Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors (Cardiac-CV)
13. juni 2013 opdateret af: Epic Research & Diagnostics, Inc.
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.
Studieoversigt
Status
Suspenderet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
60
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Mission Viejo, California, Forenede Stater, 92691
- Mission Internal Medical Group
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Association of ClearView scan with cardiovascular risk indicators
Tidsramme: Single Study Vist, no follow-up.
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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.
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Single Study Vist, no follow-up.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael Miyamoto, MD, Mission Internal Medical Group
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2012
Primær færdiggørelse (Forventet)
1. juni 2013
Studieafslutning (Forventet)
1. juni 2013
Datoer for studieregistrering
Først indsendt
16. november 2012
Først indsendt, der opfyldte QC-kriterier
30. november 2012
Først opslået (Skøn)
4. december 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. juni 2013
Sidst verificeret
1. juni 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EPIC-006
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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Kliniske forsøg med Hjerte-kar-sygdomme
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Ottawa Hospital Research InstituteAfsluttetStress | Crisis Resource Management (CRM) færdigheder | Advanced Cardiovascular Life Support (ACLS) færdighederCanada