Anatomical Assessment Versus Pull Back RFR Measurement

NCT ID: NCT04857762

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-03-01

Brief Summary

The READY register is a multicenter open label registry of patients underwent invasive intracoronary FFR and RFR measurement using the Quantien system. The register collects clinical and epidemiological data of patients scheduled for invasive coronary physiology.

Detailed Description

Angiographic evaluation protocol:

Coronary diagnostic angiography is performed according to the routine clinical practice. The visual estimate of the diameters stenosis % of the culprit lesion(s) should be input prospectively in the modified Syntax segmentation scheme (https://coronart.hu/) where the corresponding ventricular segments supply is indicated on a polar map. On the same time, the operator is required to record characterize the coronary vessel disease as focal, diffuse or mixed type, and to document his plan for angioplasty on the basis of the visual assessment. The number and length of stents planned for implantation for each patient should be also documented on the basis of visual estimation before the physiological measurements.

Invasive coronary physiology assessment protocol:

PressurewireX will be advanced distally to the investigated lesion(s) of a coronary artery. Resting and hyperemic average pressures will be determined in this distal position (in FFR mode).

A resting manual pullback with 1-2 mm/s speed will be performed (in RFR mode) under simultaneous fluoroscopic control. The "store fluoro" option of the X-ray system allows the co-registration of the pressure drop(s) to the epicardial lesion(s) on the basis of the same time scale of the pullback and the stored fluoro. The use of marker(s) in the Quantien software can enhance the identification of the culprit interval(s) of the pressure pullback curve and the related angiographic details.

A substudy of the register is planned to achieve extended physiological assessment in patients with the suspicion of microvascular disease in line with the latest ESC guideline stressing the role of microcirculatory dysfunction in the adverse outcome events in patients with non-significant coronary stenoses by FFR (class IIa, level B recommendation).

According to the intracoronary average pressure values the pressure bounded CFR interval will be calculated (CFRpb). If the cut-off value CFR=2 lies inside the defined CFRpb interval, then a novel CFR calculation based on three-dimensional reconstruction and simple flow dynamic modelling will be performed to get the exact CFRp-3D value in order to diagnose or exclude microvascular disease. One simple possibility for the characterization of the microvasculature is to define the CFR/FFR index. This value below 2 indicate impaired microvascular vasodilator capacity. For getting more precise microvascular parameter, the flow modeling using the data of the 3D coronary reconstruction and the intracoronary pressure values will provide the microvascular resistance reserve (MRR).

Offline 3D angiographic reconstruction will be performed from the selected two angiograms of good quality, with at least 25◦ difference in angle, using dedicated 3D software.

Statistical Analysis:

Normal distribution will be tested. Descriptive statistics are planned as mean and SD, median (interquartile range), or counts (%) as appropriate. Categorical variables will be compared with the Pearson χ2test. Correlation among variables will be determined by calculating Spearman ρ correlation coefficient. All analyses will be performed in Medcalc program.

Conditions

Coronary Artery Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• At least one lesion on coronary artery branch greater than 2 mm in diameter assessed as 40-90% narrowing by visual estimation
• Invasive intracoronary FFR and RFR measurement using the Quantien system according to clinical decision

Exclusion Criteria

• Patients with acute coronary syndrome
• Left main disease
• Contraindication for adenosine
• Coronary artery bypass graft on the investigated vessel
• Severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73 m2)
• Coronary angiography and pressure recordings not suitable for evaluation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Premier G Med Cardio Ltd.

UNKNOWN

Sponsor Role: collaborator

Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching H

OTHER

Sponsor Role: lead

Responsible Party

Zsolt Kőszegi

head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Heart Center Graz, Division of Cardiology, Medical University Graz

Graz, , Austria

Department of Cardiology, Faculty of Medicine, University of Debrecen

Debrecen, , Hungary

Bacs-Kiskun County Hospital Recruiting Kecskemet, Hungary,

Kecskemét, , Hungary

Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching Hospital

Nyíregyháza, , Hungary

Heart Institute, Medical School, University of Pécs

Pécs, , Hungary

Invasive Cardiology Unit, Cardiology Center, University of Szeged

Szeged, , Hungary

Countries

Austria; Hungary

Central Contacts

Zsolt Kőszegi, MD, PhD

Role: CONTACT

dr.koszegi.zsolt@szszbmk.hu

+36-30-2589442

Zoltán Molnár, MD

Role: CONTACT

dr.molnar.zoltan@szszbmk.hu

+36-42-599700

Facility Contacts

Gábor G Tóth, MD, PhD

Role: primary

gabor.g.toth@medunigraz.at

Tibor Szűk, MD, PhD

Role: primary

tszuk01@gmail.com

Balázs Berta, MD, PhD

Role: primary

bertab@kmk.hu

Áron Üveges, MD

Role: primary

aronaok@gmail.com

+3642-599700

András Komócsi, MD, PhD, DSc

Role: primary

komocsi.andras@pte.hu

Zoltán Ruzsa, MD, PhD

Role: primary

zruzsa25@gmail.com

References

Gould KL, Lipscomb K, Hamilton GW. Physiologic basis for assessing critical coronary stenosis. Instantaneous flow response and regional distribution during coronary hyperemia as measures of coronary flow reserve. Am J Cardiol. 1974 Jan;33(1):87-94. doi: 10.1016/0002-9149(74)90743-7. No abstract available.

Reference Type: BACKGROUND

PMID: 4808557 (View on PubMed)

Gould KL. Does coronary flow trump coronary anatomy? JACC Cardiovasc Imaging. 2009 Aug;2(8):1009-23. doi: 10.1016/j.jcmg.2009.06.004.

Reference Type: BACKGROUND

PMID: 19679290 (View on PubMed)

Beauman GJ, Vogel RA. Accuracy of individual and panel visual interpretations of coronary arteriograms: implications for clinical decisions. J Am Coll Cardiol. 1990 Jul;16(1):108-13. doi: 10.1016/0735-1097(90)90465-2.

Reference Type: BACKGROUND

PMID: 2358583 (View on PubMed)

Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

Reference Type: BACKGROUND

PMID: 30165437 (View on PubMed)

Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.

Reference Type: BACKGROUND

PMID: 31504439 (View on PubMed)

Patel MR, Calhoon JH, Dehmer GJ, Grantham JA, Maddox TM, Maron DJ, Smith PK. Correction to: ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria for Coronary Revascularization in Patients With Stable Ischemic Heart Disease. J Nucl Cardiol. 2018 Dec;25(6):2191-2192. doi: 10.1007/s12350-018-1292-x.

Reference Type: BACKGROUND

PMID: 29748874 (View on PubMed)

Jeremias A, Davies JE, Maehara A, Matsumura M, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp A, Ali ZA, Mintz G, Patel M, Stone GW. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):1991-2001. doi: 10.1016/j.jcin.2019.05.054.

Reference Type: BACKGROUND

PMID: 31648761 (View on PubMed)

Warisawa T, Cook CM, Howard JP, Ahmad Y, Doi S, Nakayama M, Goto S, Yakuta Y, Karube K, Shun-Shin MJ, Petraco R, Sen S, Nijjer S, Al Lamee R, Ishibashi Y, Matsuda H, Escaned J, di Mario C, Francis DP, Akashi YJ, Davies JE. Physiological Pattern of Disease Assessed by Pressure-Wire Pullback Has an Influence on Fractional Flow Reserve/Instantaneous Wave-Free Ratio Discordance. Circ Cardiovasc Interv. 2019 May;12(5):e007494. doi: 10.1161/CIRCINTERVENTIONS.118.007494.

Reference Type: BACKGROUND

PMID: 31084237 (View on PubMed)

Svanerud J, Ahn JM, Jeremias A, van 't Veer M, Gore A, Maehara A, Crowley A, Pijls NHJ, De Bruyne B, Johnson NP, Hennigan B, Watkins S, Berry C, Oldroyd KG, Park SJ, Ali ZA. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention. 2018 Sep 20;14(7):806-814. doi: 10.4244/EIJ-D-18-00342.

Reference Type: BACKGROUND

PMID: 29790478 (View on PubMed)

Van't Veer M, Pijls NHJ, Hennigan B, Watkins S, Ali ZA, De Bruyne B, Zimmermann FM, van Nunen LX, Barbato E, Berry C, Oldroyd KG. Comparison of Different Diastolic Resting Indexes to iFR: Are They All Equal? J Am Coll Cardiol. 2017 Dec 26;70(25):3088-3096. doi: 10.1016/j.jacc.2017.10.066.

Reference Type: BACKGROUND

PMID: 29268922 (View on PubMed)

Hoshino M, Yonetsu T, Sugiyama T, Kanaji Y, Hamaya R, Kanno Y, Hada M, Yamaguchi M, Sumino Y, Usui E, Hirano H, Horie T, Nogami K, Ueno H, Misawa T, Murai T, Lee T, Kakuta T. All Resting Physiological Indices May Not Be Equivalent - Comparison Between the Diastolic Pressure Ratio and Resting Full-Cycle Ratio. Circ J. 2020 Jun 25;84(7):1147-1154. doi: 10.1253/circj.CJ-19-1110. Epub 2020 Jun 4.

Reference Type: BACKGROUND

PMID: 32493861 (View on PubMed)

Koszegi Z, Berta B, Toth GG, Tar B, Uveges A, Agoston A, Szucs A, Szabo GT, Barta J, Szuk T, Czuriga D, Komocsi A, Ruzsa Z. Anatomical Assessment vs. Pullback REsting full-cycle rAtio (RFR) Measurement for Evaluation of Focal and Diffuse CoronarY Disease: Rationale and Design of the "READY Register". Front Cardiovasc Med. 2021 Dec 13;8:784220. doi: 10.3389/fcvm.2021.784220. eCollection 2021.

Reference Type: DERIVED

PMID: 34966799 (View on PubMed)

Other Identifiers

1292/2021

Identifier Type: -

Identifier Source: org_study_id