Clinical trial NCT02795585: The Wire-free Invasive Functional Imaging (WIFI) Study
Official title: Feasibility of On-line Computed Fractional Flow Reserve: The Wire-free Invasive Functional Imaging (WIFI) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Fractional Flow Reserve
Coronary Artery Disease
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stable angina pectoris admitted for coronary angiography due to high risk of significant coronary stenosis.

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).

Eligibility criteria: Inclusion Criteria:

* Stable angina pectoris and secondary evaluation of stenosis after acute myocardial infarction (AMI)
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of in-procedure QFR
timeFrame: 1 hour
Secondary outcomes:
measure: Proportion of patients with positive QFR of FFR positive patients (true positives) (sensitivity)
timeFrame: 1 hour
measure: Proportion of patients with negative QFR of patients with negative FFR (true negatives) (specificity)
timeFrame: 1 hour
measure: Proportion of patients with positive FFR (true positives) of patients with positive QFR (positive predictive value)
timeFrame: 1 hour
measure: Proportion of patients with negative FFR (true negatives) of patients with negative QFR (negative predictive value)
timeFrame: 1 hour
measure: Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio
timeFrame: 1 hour
measure: Diagnostic accuracy of QFR in comparison to 2D quantitative coronary angiography (QCA) (>50% diameter stenosis)
timeFrame: 1 hour
measure: Diagnostic accuracy of QFR based on fixed hyperemic flow rate (in-procedure analysis)
timeFrame: 1 hour
measure: Diagnostic accuracy of QFR based on Thrombolysis in Myocardial Infarction(TIMI) flow without hyperemia (in-procedure analysis)
timeFrame: 1 hour
measure: Diagnostic accuracy of QFR based on TIMI flow with hyperemia (core laboratory analysis)
timeFrame: 1 hour
measure: Any QFR procedure-related adverse events/complications (safety)
timeFrame: 1 hour
measure: Time to FFR
timeFrame: 1 hour
measure: Time to QFR
timeFrame: 1 hour
measure: Contrast use
timeFrame: 1 hour
measure: Fluoroscopy time
timeFrame: 1 hour
measure: Myocardial infarction
timeFrame: 1 year
measure: Target lesion failure
timeFrame: 1 year
measure: Target lesion revascularization
timeFrame: 1 year
measure: Stent thrombosis
timeFrame: 1 year
measure: Angina pectoris
timeFrame: 1 year
measure: Cardiac death
timeFrame: 1 year
measure: Non-cardiac death
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hspital
Study officials:
affiliation: Aarhus University Hospital
name: Niels R. Holm, M.D.
role: PRINCIPAL_INVESTIGATOR
References: