Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT (OPTICO-LM)

February 8, 2023 updated by: University Hospital Inselspital, Berne

Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascularization. Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of coronary angiography with its excellent negative predictive value, while the positive predictive value of CTA is limited. Computational fluid dynamics is an emerging method that enables prediction of blood flow in coronary arteries and calculation of FFR from computed tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional significance would bring a great benefit for patients with LM stenosis, however, there are no data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and minimal lumen area derived by OCT.

This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference standard.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • Centre Hospitalier Universitaire de Clermont-Ferrand
      • Paris, France, 75014
        • Recruiting
        • Institute Mutualiste Montsouris
      • Saint-Denis, France, 75014
        • Recruiting
        • Centre Cardiologique du Nord
  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie
    • Hesse
      • Gießen, Hesse, Germany, 35392
        • Recruiting
        • Universitätsklinikum Giessen Justus-Liebig Universität
  • Japan
      • Ageo, Japan, 362-8588
        • Recruiting
        • Ageo Central General Hospital
      • Gifu, Japan, 500-8384
        • Recruiting
        • Gifu Heart Center
      • Nagano, Japan, 390-8621
        • Recruiting
        • Department of Cardiovascular Medicine Shinshu University School of Medicine
      • Osaka, Japan, 573-1010
        • Recruiting
        • Kansai Medical University,
      • Saitama, Japan, 359-1142
        • Recruiting
        • Medical Corporation Ouyuukai Tokorozawa Heart Center
      • Sapporo, Japan, 065-0033
        • Recruiting
        • Sapporo Higashi Tokushukai Hospital
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital
      • Lausanne, Switzerland, 1011
        • Recruiting
        • CHUV

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unprotected LM lesion [midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)] of 30% to 80% angiographic diameter stenosis (DS) on visual estimation or equivocal disease by angiography.
  • Age ≥18 years.
  • Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures.

Exclusion Criteria:

  • Significant distal lesions (>50% angiographic DS on visual estimation within the left anterior descending artery [LAD] or left circumflex artery [LCX], except for ostium of LAD or LCX or diseased side branch [e.g. diagonal branch, obtuse marginal branch])
  • Ostial LM disease.
  • Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI).
  • LM In-stent restenosis.
  • Previous coronary stenting of the left coronary system.
  • Chronic total occlusion.
  • Previous coronary artery bypass graft.
  • Previous MI related to the left coronary artery.
  • Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion.
  • The presence of hemodynamic instability.
  • Known renal insufficiency (serum creatinine >1.5mg/dL or receiving dialysis).
  • Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
  • Life expectancy less than 1 year.
  • Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine.
  • Body mass index >35kg/m2.
  • Complex congenital heart disease other than anomalous coronary origins alone.
  • Ventricular septal defect.

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patient with left-main stenosis
Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT
Diagnostic test: OCT, FFR, CTA and FFRCT
Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT vs. FFR
Time Frame: Measurement at Procedure/ Baseline Visit
- The area under the curve of OCT-derived MLA for FFR≤0.8
Measurement at Procedure/ Baseline Visit
OCT vs. FFR
Time Frame: Measurement at Procedure/ Baseline Visit
-The optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.8
Measurement at Procedure/ Baseline Visit
FFRCT vs. FFR
Time Frame: Measurement at Procedure/ Baseline Visit
Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FFRCT≤0.8 for FFR≤0.8
Measurement at Procedure/ Baseline Visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT vs. FFR, RFR, resting Pd/Pa, FFRCT, QFR
Time Frame: Measurement at Procedure/ Baseline Visit
- The area under the curve and the optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80
Measurement at Procedure/ Baseline Visit
OCT vs. FFR, RFR, resting Pd/Pa, FFRCT
Time Frame: Measurement at Procedure/ Baseline Visit
- Predictability of MLA, minimal lumen diameter, area stenosis, lesion length, eccentricity index, and plaque characteristics (plaque rupture, fibroatheroma, and calcification) for FFR ≤0.8, FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80
Measurement at Procedure/ Baseline Visit
OCT vs. FFR, RFR, resting Pd/Pa, FFRCT
Time Frame: Measurement at Procedure/ Baseline Visit
- Correlation among OCT-derived MLA, FFR, RFR, resting Pd/Pa, and FFRCT and QFR
Measurement at Procedure/ Baseline Visit
OCT vs. CTA
Time Frame: Measurement at Procedure/ Baseline Visit
- Correlation between luminal diameter stenosis of CTA and OCT-derived MLA
Measurement at Procedure/ Baseline Visit
OCT vs. CTA
Time Frame: Measurement at Procedure/ Baseline Visit
- Diagnostic accuracy of plaque characteristics with presumed high risk characteristics including napkin ring sign, low attenuation plaque (<30HU), positive remodelling (remodelling index >1.1), and spotty calcium (<3mm) for thin and thick cap fibroatheroma by OCT.
Measurement at Procedure/ Baseline Visit
Clinical endpoint at 1 year
Time Frame: 12 Month
Death
12 Month
Clinical endpoint at 1 year
Time Frame: 12 Month
Myocardial infarction
12 Month
Clinical endpoint at 1 year
Time Frame: 12 Month
Target vessel myocardial infarction
12 Month
Clinical endpoint at 1 year
Time Frame: 12 Month
Target lesion revascularization
12 Month
Clinical endpoint at 1 year
Time Frame: 12 Month
Target vessel revascularization
12 Month
Clinical endpoint at 1 year
Time Frame: 12 Month
Any revascularization
12 Month
Clinical endpoint at 1 year
Time Frame: 12 Month
Stent thrombosis
12 Month
Clinical endpoint at 1 year
Time Frame: 12 Month
Stroke and transient ischemic attack
12 Month
Clinical endpoint at 1 year
Time Frame: 12 Month
Acute renal failure
12 Month

Collaborators and Investigators

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

Sponsor

University Hospital Inselspital, Berne

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 (ACTUAL)

May 28, 2019

Primary Completion (ANTICIPATED)

December 31, 2026

Study Completion (ANTICIPATED)

December 31, 2026

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 25, 2019

First Posted (ACTUAL)

January 29, 2019

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTICO-LM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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