Coronary Artery DiseaseWIFINCT02795585
The Wire-free Invasive Functional Imaging (WIFI) Study
An observational study of Coronary Artery Disease, run by Niels Ramsing Holm at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- QFR (observational)
- How many people
- 99 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Mar 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable angina pectoris admitted for coronary angiography due to high risk of significant coronary stenosis.
Who may be able to join
- Stable angina pectoris and secondary evaluation of stenosis after acute myocardial infarction (AMI)
- Age > 18 years
- Signed informed consent
Who cannot join
- 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
Show all 9Show fewer
- Ostial left main stenosis
- Severe tortuosity
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of On-line Computed Fractional Flow Reserve: The Wire-free Invasive Functional Imaging (WIFI) Study
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.
Read the 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).
- Conditions
- Coronary Artery Disease
- Being tested
- QFR (observational)
- Keywords
- Fractional Flow Reserve, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QFR (observational)Other
QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands
| Study group | Role | What they receive |
|---|---|---|
| QFR group | Patients with stable angina pectoris and indication for FFR. Receives: Other: QFR (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of in-procedure QFR
Percentage of successful QFR in FFR-cases.
Measured: 1 hour
Secondary outcomes (21)
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
Measured: 1 hour
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
Measured: 1 hour
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
Measured: 1 hour
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
Measured: 1 hour
Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio
Measured: 1 hour
Diagnostic accuracy of QFR in comparison to 2D quantitative coronary angiography (QCA) (>50% diameter stenosis)
Defined as area under the receiver operating curve (ROC)
Measured: 1 hour
Diagnostic accuracy of QFR based on fixed hyperemic flow rate (in-procedure analysis)
Defined as area under the receiver operating curve (ROC)
Measured: 1 hour
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)
Measured: 1 hour
Diagnostic accuracy of QFR based on TIMI flow with hyperemia (core laboratory analysis)
Defined as area under the receiver operating curve (ROC)
Measured: 1 hour
Any QFR procedure-related adverse events/complications (safety)
Death, myocardial infarction, acute renal failure clearly related to additional angiographic projections.
Measured: 1 hour
Time to FFR
From last diagnostic angiogram before advancing FFR-wire to approved drift-check
Measured: 1 hour
Time to QFR
From receiving angiographic images to QFR-value
Measured: 1 hour
Contrast use
Volume of contrast for total procedure
Measured: 1 hour
Fluoroscopy time
Measured: 1 hour
Myocardial infarction
Universal definition
Measured: 1 year
Target lesion failure
Universal definition
Measured: 1 year
Target lesion revascularization
Universal definition
Measured: 1 year
Stent thrombosis
Universal definition
Measured: 1 year
Angina pectoris
Canadian Cardiovascular Society (CCS)-class
Measured: 1 year
Cardiac death
Universal definition
Measured: 1 year
Non-cardiac death
Universal definition
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start9 Mar 2016
- Primary completion6 Jun 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niels Ramsing Holm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Niels Ramsing Holm, Aarhus University Hospital Skejby
- Investigators
- Niels R. Holm, M.D., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795585
- Sponsor's protocol ID
- 1-10-72-272-15
- Acronym
- WIFI
- Status last verified
- Jun 2019
- First submitted
- 29 Apr 2016
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of On-line Computed Fractional Flow Reserve: The Wire-free Invasive Functional Imaging (WIFI) Study
- ClinicalTrials.gov ID
- NCT02795585
- Acronym / sponsor ID
- WIFI / 1-10-72-272-15
- Conditions
- Coronary Artery Disease
- Keywords
- Fractional Flow Reserve, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Niels Ramsing HolmUniversity, hospital or other
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 6 Jun 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QFR group | – | Other: QFR (observational)Patients with stable angina pectoris and indication for FFR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable angina pectoris admitted for coronary angiography due to high risk of significant coronary stenosis.
Key inclusion criteria (3 listed)
- Stable angina pectoris and secondary evaluation of stenosis after acute myocardial infarction (AMI)
- Age > 18 years
- Signed informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QFR (observational)QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands | Other | QFR group |
Primary outcome
Feasibility of in-procedure QFR
Time frame: 1 hour
Percentage of successful QFR in FFR-cases.
21 secondary outcomes
Proportion of patients with positive QFR of FFR positive patients (true positives) (sensitivity)
Time frame: 1 hour
Proportion of patients with negative QFR of patients with negative FFR (true negatives) (specificity)
Time frame: 1 hour
Proportion of patients with positive FFR (true positives) of patients with positive QFR (positive predictive value)
Time frame: 1 hour
Proportion of patients with negative FFR (true negatives) of patients with negative QFR (negative predictive value)
Time frame: 1 hour
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
Diagnostic accuracy of QFR based on fixed hyperemic flow rate (in-procedure analysis)
Time frame: 1 hour
Diagnostic accuracy of QFR based on Thrombolysis in Myocardial Infarction(TIMI) flow without hyperemia (in-procedure analysis)
Time frame: 1 hour
Diagnostic accuracy of QFR based on TIMI flow with hyperemia (core laboratory analysis)
Time frame: 1 hour
Any QFR procedure-related adverse events/complications (safety)
Time frame: 1 hour
Time to FFR
Time frame: 1 hour
Time to QFR
Time frame: 1 hour
Contrast use
Time frame: 1 hour
Fluoroscopy time
Time frame: 1 hour
Myocardial infarction
Time frame: 1 year
Target lesion failure
Time frame: 1 year
Target lesion revascularization
Time frame: 1 year
Stent thrombosis
Time frame: 1 year
Angina pectoris
Time frame: 1 year
Cardiac death
Time frame: 1 year
Non-cardiac death
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels R. Holm, M.D. principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Niels Ramsing Holm at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of in-procedure QFR (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.