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The Wire-free Invasive Functional Imaging (WIFI) Study (WIFI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795585
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Niels Ramsing Holm, Aarhus University Hospital Skejby

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Other: QFR (observational)

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).

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Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of On-line Computed Fractional Flow Reserve: The Wire-free Invasive Functional Imaging (WIFI) Study
Actual Study Start Date : March 9, 2016
Actual Primary Completion Date : June 6, 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
QFR group
Patients with stable angina pectoris and indication for FFR.
Other: QFR (observational)
QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands




Primary Outcome Measures :
  1. Feasibility of in-procedure QFR [ Time Frame: 1 hour ]
    Percentage of successful QFR in FFR-cases.


Secondary Outcome Measures :
  1. Proportion of patients with positive QFR of FFR positive patients (true positives) (sensitivity) [ Time Frame: 1 hour ]
    Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80

  2. Proportion of patients with negative QFR of patients with negative FFR (true negatives) (specificity) [ Time Frame: 1 hour ]
    Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80

  3. Proportion of patients with positive FFR (true positives) of patients with positive QFR (positive predictive value) [ Time Frame: 1 hour ]
    Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80

  4. Proportion of patients with negative FFR (true negatives) of patients with negative QFR (negative predictive value) [ Time Frame: 1 hour ]
    Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80

  5. Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio [ Time Frame: 1 hour ]
  6. Diagnostic accuracy of QFR in comparison to 2D quantitative coronary angiography (QCA) (>50% diameter stenosis) [ Time Frame: 1 hour ]
    Defined as area under the receiver operating curve (ROC)

  7. Diagnostic accuracy of QFR based on fixed hyperemic flow rate (in-procedure analysis) [ Time Frame: 1 hour ]
    Defined as area under the receiver operating curve (ROC)

  8. Diagnostic accuracy of QFR based on Thrombolysis in Myocardial Infarction(TIMI) flow without hyperemia (in-procedure analysis) [ Time Frame: 1 hour ]
    Defined as area under the receiver operating curve (ROC)

  9. Diagnostic accuracy of QFR based on TIMI flow with hyperemia (core laboratory analysis) [ Time Frame: 1 hour ]
    Defined as area under the receiver operating curve (ROC)

  10. Any QFR procedure-related adverse events/complications (safety) [ Time Frame: 1 hour ]
    Death, myocardial infarction, acute renal failure clearly related to additional angiographic projections.

  11. Time to FFR [ Time Frame: 1 hour ]
    From last diagnostic angiogram before advancing FFR-wire to approved drift-check

  12. Time to QFR [ Time Frame: 1 hour ]
    From receiving angiographic images to QFR-value

  13. Contrast use [ Time Frame: 1 hour ]
    Volume of contrast for total procedure

  14. Fluoroscopy time [ Time Frame: 1 hour ]
  15. Myocardial infarction [ Time Frame: 1 year ]
    Universal definition

  16. Target lesion failure [ Time Frame: 1 year ]
    Universal definition

  17. Target lesion revascularization [ Time Frame: 1 year ]
    Universal definition

  18. Stent thrombosis [ Time Frame: 1 year ]
    Universal definition

  19. Angina pectoris [ Time Frame: 1 year ]
    Canadian Cardiovascular Society (CCS)-class

  20. Cardiac death [ Time Frame: 1 year ]
    Universal definition

  21. Non-cardiac death [ Time Frame: 1 year ]
    Universal definition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stable angina pectoris admitted for coronary angiography due to high risk of significant coronary stenosis.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795585


Locations
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Denmark
Aarhus University Hspital
Aarhus N, Denmark, 8200
Sponsors and Collaborators
Niels Ramsing Holm
Investigators
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Principal Investigator: Niels R. Holm, M.D. Aarhus University Hospital
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Responsible Party: Niels Ramsing Holm, Research associate, M.D., Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT02795585    
Other Study ID Numbers: 1-10-72-272-15
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Niels Ramsing Holm, Aarhus University Hospital Skejby:
Fractional Flow Reserve
Coronary Artery Disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases