Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
99 participants
OBSERVATIONAL
2016-03-09
2017-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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QFR group
Patients with stable angina pectoris and indication for FFR.
QFR (observational)
QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands
Interventions
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QFR (observational)
QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Signed informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Niels Ramsing Holm
OTHER
Responsible Party
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Niels Ramsing Holm
Research associate, M.D.
Principal Investigators
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Niels R. Holm, M.D.
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hspital
Aarhus N, , Denmark
Countries
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Other Identifiers
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1-10-72-272-15
Identifier Type: -
Identifier Source: org_study_id
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