Anatomical Assessment Versus Pull Back RFR Measurement (READY)

April 21, 2021 updated by: Zsolt Kőszegi, Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching H

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria
        • University Heart Center Graz, Division of Cardiology, Medical University Graz
        • Contact:
  • Hungary
      • Debrecen, Hungary
        • Department of Cardiology, Faculty of Medicine, University of Debrecen
        • Contact:
      • Kecskemét, Hungary
        • Bacs-Kiskun County Hospital Recruiting Kecskemet, Hungary,
        • Contact:
      • Nyíregyháza, Hungary, 4400
        • Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital, András Jósa Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Zsolt Kőszegi, MD, PhD
        • Sub-Investigator:
          • Balázs Tar, MD
      • Pécs, Hungary
        • Heart Institute, Medical School, University of Pécs
        • Contact:
      • Szeged, Hungary
        • Invasive Cardiology Unit, Cardiology Center, University of Szeged

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary artery disease between 18-85 years.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Comparison of the planned number of stents on the basis of 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.
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 length of the planned stent(s) on the basis of visual estimation versus RFR
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Premier G Med Cardio Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1292/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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