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Diagnostic Agreement of iFR and QFR. (DETECTISCHEMIA)

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ClinicalTrials.gov Identifier: NCT03420131
Recruitment Status : Unknown
Verified January 2018 by Christoph Jensen, MD Associate Prof., Contilia Clinical Research Institute.
Recruitment status was:  Recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Christoph Jensen, MD Associate Prof., Contilia Clinical Research Institute

Study Description
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Brief Summary:
A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.

Condition or disease Intervention/treatment
Fractional Flow Reserve, Myocardial Coronary Artery Disease Diagnostic Test: QFR and iFR

Detailed Description:

During coronary angiography, intermediate stenoses can not be adequately assessed by visual assessment alone. It is necessary to evaluate the functional significance to guide their treatment.

Fractional Flow Reserve (FFR) is the current gold standard for determining this functional significance but its adoption in clinical practice remains low. The instantaneous wave-free ratio (iFR) is an alternative way to determine the flow-limiting characteristics of a coronary stenosis with a pressure wire but without the need to induce hyperemia. Large randomised trials have confirmed the non-inferiority of iFR in respect to FFR in terms of outcome.

Quantitative Flow Ratio (QFR) is another new method for evaluating the functional significance of coronary stenosis It is a software-based analysis of conventional angiographic images to estimate the pressure drop caused by a coronary stenosis. The diagnostic agreement with FFR seemed promising in the FAVOR Pilot Study and a larger trial is enrolling for confirmation.

A stepwise approach of QFR and iFR could make the functional assessment of intermediate stenoses more practical and cost-effective. However before being used as a combination in daily practice, QFR has to be validated in respect to iFR.

The primary objective of the trial is to investigate the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DETErmining the funCTional Significance of Intermediate Stenoses in isCHEMIc heArt Disease (DETECT ISCHEMIA): Diagnostic Agreement of iFR and QFR.
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : July 28, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
FFR-iFR-QFR group Diagnostic Test: QFR and iFR

iFR® (CE-Marked) is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option.

QFR® (CE-Marked) is an angio-based FFR estimation using the analytical Software QAngio XA 3D from Medis medical imaging B.V., The Netherland


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic performance of QFR in comparison to iFR [ Time Frame: 1 hour ]
    reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to iFR

  2. QFR- iFR diagnostic grey zone calculation. [ Time Frame: 1 hour ]
    QFR limits for achieving 95% sensitivity and specificity in comparison to iFR


Secondary Outcome Measures :
  1. Diagnostic performance of QFR in comparison to FFR [ Time Frame: 1 hour ]
    reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to FFR

  2. QFR- FFR diagnostic grey zone calculation. [ Time Frame: 1 hour ]
    QFR limits for achieving 95% sensitivity and specificity in comparison to FFR

  3. Diagnostic performance of iFR in comparison to FFR [ Time Frame: 1 hour ]
    reported as sensitivity, specificity, positive and negative likelihood ratio of iFR according to FFR

  4. iFR- FFR diagnostic grey zone calculation. [ Time Frame: 1 hour ]
    iFR limits for achieving 95% sensitivity and specificity in comparison to FFR

  5. effect of 3D QCA characteristics on QFR-iFR-FFR disagreement. [ Time Frame: 1 hour ]
    Influence of minimum luminal area (MLA), percentage area stenosis, lesion length, and minimum luminal diameter (MLD) and percentage diameter stenosis in the prediction of QFR-iFR-FFR disagreement.

  6. Effect of lesion location on QFR-iFR-FFR disagreement. [ Time Frame: 1 hour ]
    Evaluation of lesion location in the prediction of QFR-iFR-FFR disagreement.

  7. Effect of p20-DAC2 score in proximal and mid-LAD stenosis on QFR-iFR-FFR disagreement. [ Time Frame: 1 hour ]
    Evaluation of p20-DAC2 score in proximal and mid-LAD stenosis in in the prediction of QFR-iFR-FFR disagreement.


Other Outcome Measures:
  1. Cost analysis [ Time Frame: 1 hour ]
    Cost savings of removing the need for Adenosine by using iFR. Evaluation of costs by excess/reduced need for stenting when iFR and FFR disagree


Eligibility Criteria
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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 that undergo angiography because of symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing or abnormal noninvasive testing) and in whom hemodynamic evaluation of an intermediate stenosis is indicated should be screened and considered for participation in the trial

The trial design is set up to be representative for the patient population that under current guidelines should be evaluated with FFR. Therefore the exclusion criteria are limited to the contraindications for adenosine and previous CABG which would not allow accurate evaluation by FFR and QFR respectively.

Criteria

Inclusion Criteria:

  • Age > 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing)
  • Patients witch semi recent (>3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction.
  • Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
  • Eligible for coronary angiography and/or percutaneous coronary intervention
  • Coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.

Exclusion criteria:

  • Contraindication to adenosine administration
  • Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
Contacts and Locations
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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): NCT03420131


Contacts
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Contact: Christoph Jensen, MD, PHD 0049-201-897-86222 c.jensen@contilia.de
Contact: Pieter Ghijselinck, MD 0049-201-897-86273 p.ghijselinck@contilia.de

Locations
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Germany
Contilia heart and vascular center Recruiting
Essen, NRW, Germany, 45138
Contact: Christoph J Jensen, MD    00492018970 ext 86222    c.jensen@contilia.de   
Contact: Pieter Ghijselinck, MD    00492018970 ext 86274    p.ghijselinck@contilia.de   
Sponsors and Collaborators
Contilia Clinical Research Institute
Investigators
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Principal Investigator: Christoph j Jensen, MD contilia heart and vascular center
More Information
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Responsible Party: Christoph Jensen, MD Associate Prof., Christoph Jensen, MD, Associate Professor of medicine, Contilia Clinical Research Institute
ClinicalTrials.gov Identifier: NCT03420131    
Other Study ID Numbers: U1111-1199-4364
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christoph Jensen, MD Associate Prof., Contilia Clinical Research Institute:
instantaneous Flow Ratio
Quantitative Flow Ratio
Fractional Flow Reserve
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases