Anatomical Assessment Versus Pull Back RFR Measurement

NCT04857762 | Unknown

• 1 other identifier: 1292/2021
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 6

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.

Conditions

Coronary Artery Stenosis

Keywords

FFR, RFR

Outcome Measures

Primary Outcomes (3)

• Concordance of visual estimation and functional assessment

  Comparison of the visual estimate of coronary lesions and the functional severity of the stenosis assessed by RFR pullback both on lesion- and vessel levels.

  Baseline, before invasive functional assessment (The visual assessment is performed after the completion of the diagnostic coronary angiography, while the functional evaluation is recorded after the intracoronary physiological measurements)

• Characterization the coronary vessel for predominantly focal/diffuse or mixed type of the disease according to visual versus RFR pullback determination.

  Focal disease: ∆RFR \>0.05 for \<25mm segment length (\>0.002/mm) Diffuse disease: ∆RFR \>0.05 for \>25mm segment length If both focal and diffuse criteria are fulfilled in the investigated vessel, then mixed type disease is diagnosed

  Baseline, before invasive functional assessment (The visual assessment is performed after the completion of the diagnostic coronary angiography, while the functional evaluation is recorded after the intracoronary physiological measurements)

• Evaluation of the concordance of the therapeutic strategies (conservative/PCI/CABG) on the basis of visual evaluation versus RFR measurements.

  Comparison of the rate of indication for the individual therapeutic strategies (conservative/PCI/CABG) by visual estimation and RFR measurements.

  Baseline, pre-intervention (Theoretical clinical decision is made after the visual assessment of the diagnostic coronary angiography, while the final decision is made after the functional evaluation by intracoronary physiological measurements)

Secondary Outcomes (2)

• In cases when the operator decides stent implantation, the planned number of stents also to be investigated according to the visual estimation versus RFR measurement.

  Baseline, pre-intervention (Theoretical clinical decision is made after the visual assessment of the diagnostic coronary angiography, while the final decision is made after the functional evaluation by intracoronary physiological measurements)

• In cases when the operator decides stent implantation, the total length of the planned stent(s) also to be investigated according to the visual estimation versus RFR measurement.

  Baseline, pre-intervention (Theoretical clinical decision is made after the visual assessment of the diagnostic coronary angiography, while the final decision is made after the functional evaluation by intracoronary physiological measurements)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery disease between 18-85 years.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching H: lead
• Premier G Med Cardio Ltd.: collaborator

Study Sites (6)

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

Graz, Austria

Location

Department of Cardiology, Faculty of Medicine, University of Debrecen

Debrecen, Hungary

Location

Bacs-Kiskun County Hospital Recruiting Kecskemet, Hungary,

Kecskemét, Hungary

Location

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

Nyíregyháza, 4400, Hungary

Location

Heart Institute, Medical School, University of Pécs

Pécs, Hungary

Location

Invasive Cardiology Unit, Cardiology Center, University of Szeged

Szeged, Hungary

Location

Related Publications (12)

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• 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.

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• 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.

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• 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.

  PMID: 34966799 DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Zsolt Kőszegi, MD, PhD

CONTACT

+36-30-2589442; dr.koszegi.zsolt@szszbmk.hu

Zoltán Molnár, MD

CONTACT

+36-42-599700; dr.molnar.zoltan@szszbmk.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of department

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 23, 2021
• Study Start: May 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

AU (1); HU (5)