Coronary Artery StenosisREADYNCT04857762
Anatomical Assessment Versus Pull Back RFR Measurement
An observational study of Coronary Artery Stenosis, run by Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching H at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Stenosis
- How many people
- 500 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 May 2021to 1 Mar 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease between 18-85 years.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Hungary5 sites
Department of Cardiology, Faculty of Medicine, University of Debrecen
Debrecen
Tibor Szűk, MD, PhD, tszuk01@gmail.com
Bacs-Kiskun County Hospital Recruiting Kecskemet, Hungary,
Kecskemét
Balázs Berta, MD, PhD, bertab@kmk.hu
Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching Hospital
Nyíregyháza, 4400
Áron Üveges, MD, +3642-599700, aronaok@gmail.com
Zsolt Kőszegi, MD, PhD
Heart Institute, Medical School, University of Pécs
Pécs
András Komócsi, MD, PhD, DSc, komocsi.andras@pte.hu
Invasive Cardiology Unit, Cardiology Center, University of Szeged
Szeged
Zoltán Ruzsa, MD, PhD, zruzsa25@gmail.com
Austria1 site
University Heart Center Graz, Division of Cardiology, Medical University Graz
Graz
Gábor G Tóth, MD, PhD, gabor.g.toth@medunigraz.at
About this study
Official title: Anatomical Assessment Versus Pull Back REsting Full-cycle rAtio (RFR) Measurement for Evaluation of Focal and Diffuse Coronary Disease
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.
Read the 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
- Keywords
- FFR, RFR
- Medical subject headings
- Coronary Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Comparison of the planned number of stents on the basis of visual estimation versus RFR measurement
Measured: 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.
Comparison of the length of the planned stent(s) on the basis of visual estimation versus RFR
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching H
- Sponsor type
- University, hospital or other
- Collaborators
- Premier G Med Cardio Ltd.
- Responsible party
- Principal investigator, Zsolt Kőszegi, Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857762
- Sponsor's protocol ID
- 1292/2021
- Acronym
- READY
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 4808557Gould KL. Does coronary flow trump coronary anatomy? JACC Cardiovasc Imaging. 2009 Aug;2(8):1009-23. doi: 10.1016/j.jcmg.2009.06.004.
PubMed 19679290Beauman 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.
PubMed 2358583Neumann 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.
PubMed 30165437Knuuti 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.
PubMed 31504439Patel 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.
PubMed 29748874Jeremias 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.
PubMed 31648761Warisawa 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.
PubMed 31084237Svanerud 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.
PubMed 29790478Van'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.
PubMed 29268922Hoshino 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.
PubMed 32493861Koszegi 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.
PubMed 34966799
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Assessment Versus Pull Back REsting Full-cycle rAtio (RFR) Measurement for Evaluation of Focal and Diffuse Coronary Disease
- ClinicalTrials.gov ID
- NCT04857762
- Acronym / sponsor ID
- READY / 1292/2021
- Conditions
- Coronary Artery Stenosis
- Keywords
- FFR, RFR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching HUniversity, hospital or other
- Collaborators
- Premier G Med Cardio Ltd.
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease between 18-85 years.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance of visual estimation and functional assessment
Time frame: 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)
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.
Characterization the coronary vessel for predominantly focal/diffuse or mixed type of the disease according to visual versus RFR pullback determination.
Time frame: 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)
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
Evaluation of the concordance of the therapeutic strategies (conservative/PCI/CABG) on the basis of visual evaluation versus RFR measurements.
Time frame: 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)
Comparison of the rate of indication for the individual therapeutic strategies (conservative/PCI/CABG) by visual estimation and RFR measurements.
2 secondary outcomes
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.
Time frame: 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.
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Background: PubMed 4808557Gould 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.
- Background: PubMed 19679290Gould KL. Does coronary flow trump coronary anatomy? JACC Cardiovasc Imaging. 2009 Aug;2(8):1009-23. doi: 10.1016/j.jcmg.2009.06.004.
- Background: PubMed 2358583Beauman 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.
- Background: PubMed 30165437Neumann 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.
- Background: PubMed 31504439Knuuti 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.
- Background: PubMed 29748874Patel 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.
- Background: PubMed 31648761Jeremias 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.
- Background: PubMed 31084237Warisawa 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.
- Background: PubMed 29790478Svanerud 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.
- Background: PubMed 29268922Van'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.
- Background: PubMed 32493861Hoshino 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.
- Derived from this study: PubMed 34966799Koszegi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Stenosis, run by Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching H at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Hungary, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zsolt Kőszegi, MD, PhD (+36-30-2589442, dr.koszegi.zsolt@szszbmk.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of visual estimation and functional assessment (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04857762, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.