Diagnostic Agreement of iFR and QFR. (DETECTISCHEMIA)

DETErmining the funCTional Significance of Intermediate Stenoses in isCHEMIc heArt Disease (DETECT ISCHEMIA): Diagnostic Agreement of iFR and QFR.

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Fractional Flow Reserve, Myocardial
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45138
      • Recruiting
      • Contilia heart and vascular center
      • Contact: Christoph J Jensen, MD; Phone Number: 86222 00492018970; Email: c.jensen@contilia.de
      • Contact: Pieter Ghijselinck, MD; Phone Number: 86274 00492018970; Email: p.ghijselinck@contilia.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of QFR in comparison to iFR	reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to iFR	1 hour
QFR- iFR diagnostic grey zone calculation.	QFR limits for achieving 95% sensitivity and specificity in comparison to iFR	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of QFR in comparison to FFR	reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to FFR	1 hour
QFR- FFR diagnostic grey zone calculation.	QFR limits for achieving 95% sensitivity and specificity in comparison to FFR	1 hour
Diagnostic performance of iFR in comparison to FFR	reported as sensitivity, specificity, positive and negative likelihood ratio of iFR according to FFR	1 hour
iFR- FFR diagnostic grey zone calculation.	iFR limits for achieving 95% sensitivity and specificity in comparison to FFR	1 hour
effect of 3D QCA characteristics on QFR-iFR-FFR disagreement.	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.	1 hour
Effect of lesion location on QFR-iFR-FFR disagreement.	Evaluation of lesion location in the prediction of QFR-iFR-FFR disagreement.	1 hour
Effect of p20-DAC2 score in proximal and mid-LAD stenosis on QFR-iFR-FFR disagreement.	Evaluation of p20-DAC2 score in proximal and mid-LAD stenosis in in the prediction of QFR-iFR-FFR disagreement.	1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost analysis	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	1 hour

Collaborators and Investigators

• Sponsor: Contilia Clinical Research Institute
• Investigators: Principal Investigator: Christoph j Jensen, MD, Contilia heart and vascular center

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Anticipated): July 28, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: January 27, 2018
• First Submitted That Met QC Criteria: January 27, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: January 27, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Fractional Flow Reserve; Quantitative Flow Ratio; instantaneous Flow Ratio
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: U1111-1199-4364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No