- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02458352
Ultra Low Dose CT for CACS and AC of SPECT
Usefulness of Ultra Low Dose Cardiac CT for Coronary Calcium Scoring and for Attenuation Correction of SPECT
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Zurich, Sveits, 8091
- Department of Nuclear Medicine, University Hospital Zurich
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients referred for myocardial perfusion SPECT
- Male and Female subjects ≥18 years of age,
- Written informed consent
Exclusion Criteria:
- Pregnancy or breast-feeding
- CACS of 0 after inclusion of 10 patients with CACS 0
- Stents or implanted cardiac devices (valves, pace makers, ICD)
- Coronary artery bypass grafts
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Standard dose CT, Ultra-low dose CT
Standard dose non-contrast enhanced CT (clinically indicated) and Ultra low dose non-contrast enhanced CT (as part of the trial)
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Non-contrast enhanced CT for CACS and AC using a novel protocol for ultra low dose radiation dose exposure
Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT
Tidsramme: 1 days
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CAC and BA limits of agreement between coronary artery calcium score obtained from ultra-low-dose and standard CT. Coronary artery calcium (CAC) is a measure for quantification of coronary artery calcification based on non-contrast enhanced CT, ranging from 0 (no calcifications) to infinite. It is an arbitrary unit. Increasing CAC means higher amounts of coronary artery calcifications and is associated with worse prognosis. Bland-Altman (BA) analysis is a statistical method to compare two modalities or techniques assessing the same measure. Limits of agreement is defined as +/- twice the standard deviation of the differences between the reference method and the new modality/technique. Broader limits of agreement mean less accurate results obtained by the new modality/techniqe, while a 0 BA limit of agreement would theoretically reflect perfect agreement. |
1 days
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Intra-class Correlation Coefficient Between Segmental Relative Tracer Uptake From SPECT Datasets Reconstructed With AC Maps Based on Ultra-Low-Dose and Standard Dose CT
Tidsramme: 1 day
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For every patient, the CT images from 120 and 70 kVp-CT scans were used to create CTAC maps which were then used to reconstruct SPECT images, displayed as a 17-segment model polar plot with normalized percent tracer uptake given for every segment.
Intra-class correlation was then applied to compare segmental relative tracer uptake.
Analysis and the resulting correlation coefficient of 0.987 basically demonstrates interchangeability between the two datasets.
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1 day
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Valerie Treyer, PhD, University of Zurich
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- USZ-2015-0072
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