Diagnostic Agreement of iFR and QFR.

• Conditions: Fractional Flow Reserve, Myocardial; Coronary Artery Disease
• Interventions: Diagnostic Test: QFR and iFR

• Registration Number: NCT03420131
• Lead Sponsor: Contilia Clinical Research Institute

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.

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 Timeline

• Study Start: 2017-07-18
• Status Verified: 2018-01
• Study First Submitted: 2018-01-27
• Study First Submitted QC: 2018-01-27
• Last Update Submitted: 2018-01-27
• Study First Posted: 2018-02-05
• Last Update Posted: 2018-02-05
• Primary Completion: 2018-07-28
• Study Completion: 2018-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FFR-iFR-QFR group	QFR and iFR	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Contilia heart and vascular center; 🇩🇪 Essen, NRW, Germany