Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography (PERFECT)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Individual-Patient-Data Pooled-Analysis of Diagnostic Accuracy of Noninvasive Fractional Flow Reserve From Anatomic CT Angiography|
- Diagnostic Accuracy of FFRCT [ Time Frame: 1 day ] [ Designated as safety issue: No ]Diagnostic accuracy[Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)]* of FFRCT to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis at the subject level using binary outcomes when compared to FFR as the reference standard..*Sensitivity measures the proportion of actual positives which are correctly identified. Specificity measures the proportion of negatives which are correctly identified;PPV, or precision rate is the proportion of positive test results that are true positives (such as correct diagnoses);NPV is defined as the proportion of subjects with a negative test result who are correctly diagnosed.
- Diagnostic accuracy of FFRCT at the subject level [ Time Frame: 1 day ] [ Designated as safety issue: No ]Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FFRCT at the subject level using binary outcomes when compared to FFR as the reference standard.
- Diagnostic accuracy of FFRCT at the vessel level [ Time Frame: 1 day ] [ Designated as safety issue: No ]Sensitivity, specificity, PPV and NPV of FFRCT for the presence or absence of HD-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard.
- FFR Numerical Correlation [ Time Frame: 1 day ] [ Designated as safety issue: No ]Per-vessel correlation of the FFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Single arm study
Single arm study.The investigators will conduct computed tomography,angiography and FFR measurement during angiography in this single arm.
Device: FFR (PressureWire)
Fractional flow reserve measured during cardiac catheterization——A pressure-monitoring guidewire(PressureWire Certus, St. Jude Medical Systems, Uppsala, Sweden;ComboWire, Volcano Corporation, San Diego, California) will be advanced past the stenosis.
Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.
Available data from registered clinical trials has testified the diagnostic performance of FFRCT, but the diagnostic accuracy among them are not consistent.
Thus, the investigators designed a collaborative individual patient-data pooled-analysis aimed to assess the diagnostic accuracy of FFRCT and find the possible cause for inconsistency
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747317
|Department of Cardiology, Shanghai Tenth People's Hospital|
|Shanghai, China, 200072|
|Principal Investigator:||Ya-Wei Xu, MD, FACC||Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine|