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
|Condition or disease||Intervention/treatment|
|Fractional Flow Reserve, Myocardial Coronary Artery Disease||Diagnostic Test: QFR and iFR|
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|
|Estimated Enrollment :||250 participants|
|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|
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
- 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
- QFR- iFR diagnostic grey zone calculation. [ Time Frame: 1 hour ]QFR limits for achieving 95% sensitivity and specificity in comparison to iFR
- 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
- QFR- FFR diagnostic grey zone calculation. [ Time Frame: 1 hour ]QFR limits for achieving 95% sensitivity and specificity in comparison to FFR
- 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
- iFR- FFR diagnostic grey zone calculation. [ Time Frame: 1 hour ]iFR limits for achieving 95% sensitivity and specificity in comparison to FFR
- 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.
- 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.
- 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.
- 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
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
|Contact: Christoph Jensen, MD, PHDemail@example.com|
|Contact: Pieter Ghijselinck, MDfirstname.lastname@example.org|
|Principal Investigator:||Christoph j Jensen, MD||contilia heart and vascular center|