Determination of Instantaneous Wave-Free Ratio by Computed Tomography (iFRCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01747031|
Recruitment Status : Unknown
Verified December 2012 by Ya-Wei Xu, Shanghai 10th People's Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 11, 2012
Last Update Posted : December 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: PressureWire™ Certus(St. Jude Medical Systems, Sweden)||Not Applicable|
Noninvasive fractional flow reserve (FFR) computed from CT (FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), and several clinical trials have revealed that the FFRCT has a good correlation with invasive FFR, also use of noninvasive FFRCT plus Computed Tomography (CT ) among stable patients with suspected or known CAD was associated with improved diagnostic accuracy and discrimination vs CT alone for the diagnosis of hemodynamically significant CAD.
The cornerstone of FFR is the linear relationship between pressure and flow under conditions of constant (and minimized) intracoronary resistance, so is FFRCT. Under such conditions, pressure and flow are assumed to be directly proportional, and a decrease in pressure across a stenosis reflects a decrease in blood flow to the dependent myocardium. However, even after administration of potent pharmacologic agents such as adenosine, intracoronary resistance is not static, but instead fluctuates in a phasic pattern throughout the cardiac cycle. In addition, for patients who are allergic to pharmacologic agents or with sever lesions which response little to pharmacologic agents, the measurement of FFR is challenging and the lesion are always underestimated. The ADVISE trial revealed that intracoronary resistance is naturally constant and minimized during the wave-free period. The instantaneous wave-free ratio calculated over this period produces a drug-free index of stenosis severity comparable to FFR. But whether iFR calculated from Computed Tomography(iFRCT) is comparable to FFRCT or FFR, and its diagnostic performance remains unknown. Thus the investigators conduct this trial to assess the diagnostic performance of Instantaneous Wave-Free Ratio for diagnosis of hemodynamically significant coronary stenosis.
Instantaneous Wave-Free Ratio calculated from reconstructed heart model.Wave-intensity analysis identified a wave-free period in which intracoronary resistance at rest is similar in variability and magnitude.The investigators define the resting distal-to-proximal pressure ratio during this period as the instantaneous wave-free ratio (iFR).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Diagnostic Performance of Instantaneous Wave-Free Ratio From Computed Tomography|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||August 2014|
Experimental: Single arm study
Single arm study.The investigators will conducte computed tomography,angiography and FFR measurement during angiography in this single arm.
Device: PressureWire™ Certus(St. Jude Medical Systems, Sweden)
Fractional flow reserve measured during cardiac catheterization——A pressure-monitoring guidewire(PressureWire Certus, St. Jude Medical Systems, Uppsala, Sweden) will be advanced past the stenosis.
- Diagnostic Accuracy of iFRCT [ Time Frame: 1 day ]Diagnostic accuracy[Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)]* of CCTA plus iFRCT(instantaneous wave-free ratio calculated in reconstructed heart model) or iFRCT alone 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 iFRCT at the subject level [ Time Frame: 1 day ]Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus iFRCT or iFRCT alone at the subject level using binary outcomes when compared to FFR as the reference standard.
- Diagnostic accuracy of iFRCT at the vessel level [ Time Frame: 1 day ]Sensitivity, specificity, PPV and NPV of CCTA plus iFRCT or iFRCT alone 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 ]Per-vessel correlation of the iFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization.
- FFRCT Numerical Correlation [ Time Frame: 1 day ]Per-vessel correlation of the iFRCT numerical value alone with the FFRCT numerical value calculated from the computed tomography.
- Predicted Post-PCI FFR Measurement [ Time Frame: 1 day ]Diagnostic accuracy of predicted post-percutaneous intervention (PCI) iFRCT alone to determine success or failure of PCI* using binary outcomes when compared to post-PCI FFR at the subject and vessel level using PCI as the reference standard.*PCI success will be defined as post-PCI FFR>0.80, while PCI failure will be defined as post-PCI FFR≤0.80 during adenosine-mediated hyperemia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747031
|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|