FFR Versus iFR in Assessment of Hemodynamic Lesion Significance

NCT03033810 | Unknown

• 1 other identifier: VFN_21_2016
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Presence of endothelial dysfunction, plaque superficial irregularities and gene polymorphisms in patients with screpancies between FFR and iFR during functional assessments of coronary stenosis.

  Endothelial dysfunction measured by EndoPAT, plaque superficial irregularities measured by OCT and gene polymorphisms in ENOS and HO-1 can be different in patients with discrepancy between FFR and iFR compared to known results from patients with coronary artery disease.

  2017-2019

Secondary Outcomes (2)

• To use a new software to determine which of two methods for the functional assessment of coronary stenosis (FFR and iFR) perform their measurements during a lower level of microvascular resistance.

  2017-2019

• To develop a new version of aforementioned software for the detection of microvascular resistance level, based only on intracoronary pressures without flow analysis

  2017-2019

Study Arms (1)

Consecutive patients with FFR and iFR

Patients with stable angina pectoris with suitable for coronary angiography will be suitable for the study

Device: Fractional flow reserve and instantaneous wave-free ratio

Interventions

Fractional flow reserve and instantaneous wave-free ratio DEVICE

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.

Consecutive patients with FFR and iFR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable angina pectoris indicated for lesion hemodynamic assessment for bordeline stensois found during coronary angiography

You may qualify if:

• Stable angina pectoris
• Age 18-80 years
• Signed inform consent
• Coronary arteries without severe tortuosity and calcifications
• Normal blood flow in coronary arteries (TIMI flow III)
• Coronary artery stenosis less than 80% during CAG

You may not qualify if:

• Hemodynamic instability, cardio-pulmonary resuscitation in a same day
• Thrombosis in a target coronary artery visible during angiography
• Patients after or with planned coronary artery bypass grafting
• Severe bronchial asthma or atrio-ventricular block higher than first degree (contraindication for adenosine administration)
• Renal insufficiency with creatinine level more than 180 umol/l
• Known allergy to iodine contrast
• Pregnancy

Sponsors & Collaborators

• General University Hospital, Prague: lead
• University of Iowa: collaborator

Study Sites (1)

II. interni klinika VFN

Prague, 12808, Czechia

RECRUITING

Related Publications (22)

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• Kovarnik T, Hitoshi M, Kral A, Jerabek S, Zemanek D, Kawase Y, Omori H, Tanigaki T, Pudil J, Vodzinska A, Branny M, Stipal R, Kala P, Mrozek J, Porzer M, Grezl T, Novobilsky K, Mendiz O, Kopriva K, Mates M, Chval M, Chen Z, Martasek P, Linhart A; FiGARO trial investigators. Fractional Flow Reserve Versus Instantaneous Wave-Free Ratio in Assessment of Lesion Hemodynamic Significance and Explanation of their Discrepancies. International, Multicenter and Prospective Trial: The FiGARO Study. J Am Heart Assoc. 2022 May 3;11(9):e021490. doi: 10.1161/JAHA.121.021490. Epub 2022 May 3.

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• Jerabek S, Zemanek D, Pudil J, Bayerova K, Kral A, Kopriva K, Kawase Y, Omori H, Tanigaki T, Chen Z, Vodzinska A, Branny M, Matsuo H, Mates M, Sonka M, Kovarnik T. Endothelial dysfunction assessed by digital tonometry and discrepancy between fraction flow reserve and instantaneous wave free ratio. Acta Cardiol. 2020 Aug;75(4):323-328. doi: 10.1080/00015385.2019.1586089. Epub 2019 Apr 4.

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Biospecimen

Retention: SAMPLES WITH DNA

Genetic analysis of polymorphisms in gene for Hemoxygenase-1 and endothelial nitric oxide synthase. Patient's DNA will be isolated from peripheral blood leukocytes using standard techniques.

Central Study Contacts

Tomas Kovarnik, MD, PhD

CONTACT

+420732210677; tomas.kovarnik@vfn.cz

David Zemanek, MD, PhD

CONTACT

+42022492606; david.zemanek@vfn.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Head of Invasive Cardiology Dpt.

Study Record Dates

• First Submitted: January 8, 2017
• First Posted: January 27, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)