A Phase 4 interventional study of FFR (PressureWire) in Coronary Artery Disease, sponsored by Shanghai 10th People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-11.
Sponsored by Shanghai 10th People's Hospital · Phase 4, Interventional, and Diagnostic
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.
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
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 300 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: PressureWire™ Certus(St. Jude Medical Systems), PressureWire™ Certus(ComboWire, Volcano Corporation)
Diagnostic Accuracy of FFRCT
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.
Time frame: 1 day
Diagnostic accuracy of FFRCT at the subject level
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.
Time frame: 1 day
Diagnostic accuracy of FFRCT at the vessel level
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.
Time frame: 1 day
FFR Numerical Correlation
Per-vessel correlation of the FFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization.
Time frame: 1 day
This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Shanghai 10th People's Hospital