The Wire-free Invasive Functional Imaging (WIFI) Study (WIFI)
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|ClinicalTrials.gov Identifier: NCT02795585|
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Other: QFR (observational)|
Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG) and often in combination with measurement of fractional flow reserve (FFR) to assess the functional significance of identified stenosis. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during maximum blood flow (hyperaemia) induced by adenosine infusion.
The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy in many centers but the need for interrogating the stenosis by a pressure wire and the cost of the wire and the drug inducing hyperaemia limits more widespread adoption.
Quantitative Flow Ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure in the vessel based on two angiographic projections.
The purpose of the WIFI study is to evaluate feasibility of QFR when performed during coronary angiography and compare diagnostic accuracy to standard FFR.
QFR can be assessed during CAG for stenosis interrogated by FFR
Proof-of-concept, prospective, observational, single arm study with inclusion of 100 patients. Clinical follow-up by telephone call after one year.
A stenosis with indication for FFR is identified and at least two angiographic projections rotated at least 25 degrees around the target vessel are acquired during resting conditions. QFR is calculated on-line using the Medis Suite application and simultaneously to the operator performing the FFR measurement using I.V. adenosine. The QFR observer is blinded to the FFR measurement.
QFR is reassessed off-line by internal observer and by an external core laboratory. Both blinded to FFR results.
FFR is assessed in core laboratory by a different blinded observer
All data are entered and stored in a protected and logged trial management system (TrialPartner).
|Study Type :||Observational|
|Actual Enrollment :||99 participants|
|Official Title:||Feasibility of On-line Computed Fractional Flow Reserve: The Wire-free Invasive Functional Imaging (WIFI) Study|
|Actual Study Start Date :||March 9, 2016|
|Actual Primary Completion Date :||June 6, 2016|
|Actual Study Completion Date :||December 2017|
Patients with stable angina pectoris and indication for FFR.
Other: QFR (observational)
QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands
- Feasibility of in-procedure QFR [ Time Frame: 1 hour ]Percentage of successful QFR in FFR-cases.
- Proportion of patients with positive QFR of FFR positive patients (true positives) (sensitivity) [ Time Frame: 1 hour ]Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80
- Proportion of patients with negative QFR of patients with negative FFR (true negatives) (specificity) [ Time Frame: 1 hour ]Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80
- Proportion of patients with positive FFR (true positives) of patients with positive QFR (positive predictive value) [ Time Frame: 1 hour ]Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80
- Proportion of patients with negative FFR (true negatives) of patients with negative QFR (negative predictive value) [ Time Frame: 1 hour ]Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80
- Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio [ Time Frame: 1 hour ]
- Diagnostic accuracy of QFR in comparison to 2D quantitative coronary angiography (QCA) (>50% diameter stenosis) [ Time Frame: 1 hour ]Defined as area under the receiver operating curve (ROC)
- Diagnostic accuracy of QFR based on fixed hyperemic flow rate (in-procedure analysis) [ Time Frame: 1 hour ]Defined as area under the receiver operating curve (ROC)
- Diagnostic accuracy of QFR based on Thrombolysis in Myocardial Infarction(TIMI) flow without hyperemia (in-procedure analysis) [ Time Frame: 1 hour ]Defined as area under the receiver operating curve (ROC)
- Diagnostic accuracy of QFR based on TIMI flow with hyperemia (core laboratory analysis) [ Time Frame: 1 hour ]Defined as area under the receiver operating curve (ROC)
- Any QFR procedure-related adverse events/complications (safety) [ Time Frame: 1 hour ]Death, myocardial infarction, acute renal failure clearly related to additional angiographic projections.
- Time to FFR [ Time Frame: 1 hour ]From last diagnostic angiogram before advancing FFR-wire to approved drift-check
- Time to QFR [ Time Frame: 1 hour ]From receiving angiographic images to QFR-value
- Contrast use [ Time Frame: 1 hour ]Volume of contrast for total procedure
- Fluoroscopy time [ Time Frame: 1 hour ]
- Myocardial infarction [ Time Frame: 1 year ]Universal definition
- Target lesion failure [ Time Frame: 1 year ]Universal definition
- Target lesion revascularization [ Time Frame: 1 year ]Universal definition
- Stent thrombosis [ Time Frame: 1 year ]Universal definition
- Angina pectoris [ Time Frame: 1 year ]Canadian Cardiovascular Society (CCS)-class
- Cardiac death [ Time Frame: 1 year ]Universal definition
- Non-cardiac death [ Time Frame: 1 year ]Universal definition
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): NCT02795585
|Aarhus University Hspital|
|Aarhus N, Denmark, 8200|
|Principal Investigator:||Niels R. Holm, M.D.||Aarhus University Hospital|