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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Experimental | Single arm study.The investigators will conduct computed tomography,angiography and FFR measurement during angiography in this single arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR (PressureWire) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Diagnostic accuracy of FFRCT at the vessel level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ya-Wei Xu, MD, FACC | Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Shanghai Tenth People's Hospital | Shanghai | 200072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22032711 | Result | Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066. | |
| 22922562 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
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. |
| 1 day |
| FFR Numerical Correlation | Per-vessel correlation of the FFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization. | 1 day |
| Result |
| Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |