The Wire-free Invasive Functional Imaging (WIFI) Study

Coronary Artery Disease Clinical Trial

— WIFI  

Official title:

Feasibility of On-line Computed Fractional Flow Reserve: The Wire-free Invasive Functional Imaging (WIFI) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795585
• Other study ID #: 1-10-72-272-15
• Status: Completed
• Start date: March 9, 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2019
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2017
• Est. primary completion date: June 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• QFR (observational)
QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands

Locations

Country	Name	City	State
Denmark	Aarhus University Hspital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Niels Ramsing Holm

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of in-procedure QFR	Percentage of successful QFR in FFR-cases.	1 hour
Secondary	Proportion of patients with positive QFR of FFR positive patients (true positives) (sensitivity)	Positive FFR is defined as FFR=0.80. Positive QFR is defined as QFR=0.80	1 hour
Secondary	Proportion of patients with negative QFR of patients with negative FFR (true negatives) (specificity)	Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80	1 hour
Secondary	Proportion of patients with positive FFR (true positives) of patients with positive QFR (positive predictive value)	Positive FFR is defined as FFR=0.80. Positive QFR is defined as QFR=0.80	1 hour
Secondary	Proportion of patients with negative FFR (true negatives) of patients with negative QFR (negative predictive value)	Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80	1 hour
Secondary	Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio		1 hour
Secondary	Diagnostic accuracy of QFR in comparison to 2D quantitative coronary angiography (QCA) (>50% diameter stenosis)	Defined as area under the receiver operating curve (ROC)	1 hour
Secondary	Diagnostic accuracy of QFR based on fixed hyperemic flow rate (in-procedure analysis)	Defined as area under the receiver operating curve (ROC)	1 hour
Secondary	Diagnostic accuracy of QFR based on Thrombolysis in Myocardial Infarction(TIMI) flow without hyperemia (in-procedure analysis)	Defined as area under the receiver operating curve (ROC)	1 hour
Secondary	Diagnostic accuracy of QFR based on TIMI flow with hyperemia (core laboratory analysis)	Defined as area under the receiver operating curve (ROC)	1 hour
Secondary	Any QFR procedure-related adverse events/complications (safety)	Death, myocardial infarction, acute renal failure clearly related to additional angiographic projections.	1 hour
Secondary	Time to FFR	From last diagnostic angiogram before advancing FFR-wire to approved drift-check	1 hour
Secondary	Time to QFR	From receiving angiographic images to QFR-value	1 hour
Secondary	Contrast use	Volume of contrast for total procedure	1 hour
Secondary	Fluoroscopy time		1 hour
Secondary	Myocardial infarction	Universal definition	1 year
Secondary	Target lesion failure	Universal definition	1 year
Secondary	Target lesion revascularization	Universal definition	1 year
Secondary	Stent thrombosis	Universal definition	1 year
Secondary	Angina pectoris	Canadian Cardiovascular Society (CCS)-class	1 year
Secondary	Cardiac death	Universal definition	1 year
Secondary	Non-cardiac death	Universal definition	1 year