The Wire-free Invasive Functional Imaging (WIFI) Study
- Conditions
- Coronary Artery Disease
- Interventions
- Other: QFR (observational)
- Registration Number
- NCT02795585
- Lead Sponsor
- Niels Ramsing Holm
- Brief Summary
Quantitative Flow Ratio (QFR) is a new 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.
- Detailed Description
Background:
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.
Hypothesis:
QFR can be assessed during CAG for stenosis interrogated by FFR
Methods:
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- Stable angina pectoris and secondary evaluation of stenosis after acute myocardial infarction (AMI)
- Age > 18 years
- Signed informed consent
- Myocardial infarction within 72 hours
- Severe asthma and chronic obstructive pulmonary disease
- Severe heart failure (NYHA≥III)
- S-creatinine>120µmol/L
- Allergy to contrast media or adenosine
- Stenosis in vein graft
- Ostial left main stenosis
- Severe tortuosity
- Atrial fibrillation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description QFR group QFR (observational) Patients with stable angina pectoris and indication for FFR.
- Primary Outcome Measures
Name Time Method Feasibility of in-procedure QFR 1 hour Percentage of successful QFR in FFR-cases.
- Secondary Outcome Measures
Name Time Method Proportion of patients with negative FFR (true negatives) of patients with negative QFR (negative predictive value) 1 hour Negative FFR is defined as FFR\>0.80. Negative QFR is defined as QFR\>0.80
Diagnostic accuracy of QFR based on fixed hyperemic flow rate (in-procedure analysis) 1 hour Defined as area under the receiver operating curve (ROC)
Contrast use 1 hour Volume of contrast for total procedure
Myocardial infarction 1 year Universal definition
Proportion of patients with negative QFR of patients with negative FFR (true negatives) (specificity) 1 hour Negative FFR is defined as FFR\>0.80. Negative QFR is defined as QFR\>0.80
Time to FFR 1 hour From last diagnostic angiogram before advancing FFR-wire to approved drift-check
Stent thrombosis 1 year Universal definition
Diagnostic accuracy of QFR in comparison to 2D quantitative coronary angiography (QCA) (>50% diameter stenosis) 1 hour Defined as area under the receiver operating curve (ROC)
Diagnostic accuracy of QFR based on TIMI flow with hyperemia (core laboratory analysis) 1 hour Defined as area under the receiver operating curve (ROC)
Target lesion failure 1 year Universal definition
Cardiac death 1 year Universal definition
Non-cardiac death 1 year Universal definition
Proportion of patients with positive FFR (true positives) of patients with positive QFR (positive predictive value) 1 hour Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80
Any QFR procedure-related adverse events/complications (safety) 1 hour Death, myocardial infarction, acute renal failure clearly related to additional angiographic projections.
Proportion of patients with positive QFR of FFR positive patients (true positives) (sensitivity) 1 hour Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80
Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio 1 hour Diagnostic accuracy of QFR based on Thrombolysis in Myocardial Infarction(TIMI) flow without hyperemia (in-procedure analysis) 1 hour Defined as area under the receiver operating curve (ROC)
Fluoroscopy time 1 hour Target lesion revascularization 1 year Universal definition
Angina pectoris 1 year Canadian Cardiovascular Society (CCS)-class
Time to QFR 1 hour From receiving angiographic images to QFR-value
Trial Locations
- Locations (1)
Aarhus University Hspital
🇩🇰Aarhus N, Denmark