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

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ClinicalTrials.gov Identifier: NCT03820492
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronary Stenosis Diagnostic Test: OCT, FFR, CTA and FFRCT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. OCT vs. FFR [ Time Frame: Measurement at Procedure/ Baseline Visit ]
    - The area under the curve of OCT-derived MLA for FFR≤0.8

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. OCT vs. CTA [ Time Frame: Measurement at Procedure/ Baseline Visit ]
    - Correlation between luminal diameter stenosis of CTA and OCT-derived MLA

  5. 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.

  6. Clinical endpoint at 1 year [ Time Frame: 12 Month ]
    Death

  7. Clinical endpoint at 1 year [ Time Frame: 12 Month ]
    Myocardial infarction

  8. Clinical endpoint at 1 year [ Time Frame: 12 Month ]
    Target vessel myocardial infarction

  9. Clinical endpoint at 1 year [ Time Frame: 12 Month ]
    Target lesion revascularization

  10. Clinical endpoint at 1 year [ Time Frame: 12 Month ]
    Target vessel revascularization

  11. Clinical endpoint at 1 year [ Time Frame: 12 Month ]
    Any revascularization

  12. Clinical endpoint at 1 year [ Time Frame: 12 Month ]
    Stent thrombosis

  13. Clinical endpoint at 1 year [ Time Frame: 12 Month ]
    Stroke and transient ischemic attack

  14. Clinical endpoint at 1 year [ Time Frame: 12 Month ]
    Acute renal failure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 sign informed consent before any study-specific procedure.

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.
  • 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.
  • Presence of prosthetic heart valve, pacemaker or internal defibrillator leads.
  • Atrial fibrillation.
  • Body mass index >35kg/m2.
  • Complex congenital heart disease other than anomalous coronary origins alone.
  • Ventricular septal defect.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820492


Contacts
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Contact: Lorenz Raeber, Prof. MD PhD +41316322111 lorenz.raeber@insel.ch
Contact: Yasushi Ueki, MD +41316322111 yasushi.ueki@insel.ch

Locations
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Germany
Universitätsklinikum Giessen Justus-Liebig Universität Recruiting
Gießen, Hesse, Germany, 35392
Contact: Nef Holger, Professor    641 98556220 ext +49    Holger.Nef@innere.med.uni-giessen.de   
Japan
Gifu heart center Recruiting
Gifu, Japan, 500-8384
Contact: Matsuo Hitoshi, Dr.    58-277-2277 ext +81    matsuo@heart-center.or.jp   
Medical Corporation Ouyuukai Tokorozawa Heart Center Recruiting
Saitama, Japan, 359-1142
Contact: Taniwaki Masanori, Dr.    4 2940 8611 ext +81    grand_wagoneer_797@hotmail.com   
Switzerland
Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Lorenz Räber, Prof MD    +41 31 632 09 29    lorenz.raeber@insel.ch   
CHUV Recruiting
Lausanne, Switzerland, 1011
Contact: Stephane Fournier, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Lorenz Raeber, Prof. MD PhD Inselspital
Publications:
Mäkikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sørensen HT, Nielsen PH, Niemelä M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Fröbert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31. Erratum in: Lancet. 2016 Dec 3;388(10061):2742.

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03820492    
Other Study ID Numbers: OPTICO-LM
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Coronary artery disease
Fractional flow reserve
Optical coherence tomography
Computed tomography angiography
Additional relevant MeSH terms:
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Coronary Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases