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FFR Versus iFR in Assessment of Hemodynamic Lesion Significance

NCT03033810 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2017-01-27

No results posted yet for this study

Summary

The study will compare two invasive methods (FFR -fractional flow reserve and iFR-instantaneous wave free ratio) for assessment of hemodynamic impact of coronary stenosis on myocardial perfusion. There is a very good correlation between these methods for the assessment of hemodynamic significance in a broad spectrum of lesions. However, this correlation decreases significantly near the cut off points for each method. The investigators will try to find possible explanations for these differences by detailed morphology assessment of coronary stenosis using optical coherence tomography (OCT), analysis of gene polymorphisms that play a role in vasodilatation, and by shear stress analysis. The head-to-head comparison between FFR and iFR is not simple, because there is no "gold standard" for assessment of hemodynamic significance. Studies comparing these methods have used hyperemic stenosis resistance (HSR). For this kind of measurement it is necessary to measure the speed of blood flow. This is usually done by a Doppler analysis of flow. Unfortunately, the Doppler signal can yield many artificial or erroneous indicators, and obtaining a good quality signal is frequently time-consuming. These are the reasons that HSR has not been used in routine practice. The investigators have developed a new console and software that can provide real time analysis of the Doppler signal. It allows us to easily measure HSR, and to differentiate between the FFR and iFR measures through intrabeat analysis of microvascular resistance (lowest microvascular resistance is an essential condition for proper pressure measurement). Using this tool, it is possible to automatically identify the point of lowest microvascular resistance during each cardiac beat. The pressure gradient can then be measured at that point. This approach can eliminate almost all uncertainties in assessment of the pressure gradient produced by coronary stenosis. This tool can potentially improve the existing methods used to precisely reveal a significant stenosis. This should increase the number of hemodynamic guided procedures.

Conditions

  • Hemodynamics
  • Coronary Circulation
  • Tomography, Optical Coherence
  • Endothelial Cells
  • Polymorphism, Genetic

Interventions

DEVICE

Fractional flow reserve and instantaneous wave-free ratio

1. To explain discrepancies between FFR and iFR using demographic, morphological, genetic and functional indices. 2. The development of software for the automatic detection of the lowest point of microvascular resistance.

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER

  • General University Hospital, Prague

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-06-30
Completion
2019-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03033810 on ClinicalTrials.gov