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Coronary Plaque Monitoring using Coronary CT Angiography: Variability of CT Scanners and Observers

Not Applicable
Conditions
Coronary artery stenosis
Registration Number
JPRN-UMIN000034030
Lead Sponsor
Iwate Medical University
Brief Summary

A

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
23
Inclusion Criteria

Not provided

Exclusion Criteria

1. Age of <20 or >=85 yrs. 2. Need for early revascularization 3. History of coronary stent or bypass 4. Agatston score >1000 5. Renal dysfunction (eGFR <45 mg/dl/1.73m2) 6. Estimated radiation exposure of 15 mSv or more within 1 yr. at the time of registration. 7. Contraindication for iodine contrast medium 8. Suspected pregnancy

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary endpoints of this study are, 1. The sample size required by coronary CT angiography to show a clinical change with 90% power and an a error of .05. based on intraclass correlation coefficients. 2. Variability and agreement of CT findings of vulnerable plaque.
Secondary Outcome Measures
NameTimeMethod
The secondary endpoints of this study are, 1. Radiation dose for coronary CTA. 2. Reproducibility of coronary calcium score 3. Reproducibility of diameter stenosis 4. Reproducibility of wall volume 5. Reproducibility of lumen volume
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