Relationship Between OCT Coronary Plaque Morphology and Clinical Outcome
NCT ID: NCT02883088
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1003 participants
OBSERVATIONAL
2013-01-01
2019-12-01
Brief Summary
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Detailed Description
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Identification of these plaque features with imaging modalities is potentially a valid approach to identify patients at increased risk of M (5). Optical coherence tomography is capable of visualizing superficial plaque components at a high resolution (in the range of 10-15 microns) and can depict all the features of plaque vulnerability or thrombogenicity (6,7).
The aim of the study is to relate presence of multiple OCT criteria of plaque vulnerability with following clinical events in a subset of coronary lesions. For this purpose all plaques in the proximal-mid portion of the left anterior descending artery will be evaluated with FD-OCT assessing the following criteria:
* minimum lumen area (MLA) \<3.5 mm2:
* fibrous cap minimum thickness \<75 µm:
* lipid arc extension \>180°;
* presence of macrophages;
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LAD-group
Subjects over 18 years who are undergoing Frequency Domain - Optical Coherence Tomography (FD-OCT) evaluation of the native left anterior descending artery during clinically indicated coronary angiography regardless of the clinical syndrome (silent ischemia, effort angina or acute coronary syndrome).
Frequency Domain - Optical Coherence Tomography (FD-OCT)
FD-OCT assessment of the native proximal-mid left descending artery during clinically indicated coronary angiography
Interventions
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Frequency Domain - Optical Coherence Tomography (FD-OCT)
FD-OCT assessment of the native proximal-mid left descending artery during clinically indicated coronary angiography
Eligibility Criteria
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Inclusion Criteria
* Patients with clinical indication to coronary angiography undergoing OCT evaluation of the left anterior descending artery regardless of the clinical syndrome;
* Patients with at least 30 mm of naïve OCT-assessable proximal-mid left anterior descending artery;
* Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent to the procedure;
Exclusion Criteria
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
* Advanced heart failure (NYHA III-IV)
* Previous Coronary artery by-pass surgery
* Previous stenting of proximal-mid left anterior descending artery with residual untreated segment \<30mm.
* Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
* Heavily calcified vessel and/or lesion which cannot be successfully imaged by OCT
18 Years
90 Years
ALL
No
Sponsors
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Centro per la Lotta Contro l'Infarto - Fondazione Onlus
OTHER
San Giovanni Addolorata Hospital
OTHER
Responsible Party
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Francesco Prati
Dr.
Principal Investigators
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Francesco Prati, MD
Role: PRINCIPAL_INVESTIGATOR
San Giovanni Addolorata Hospital
Locations
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Policlinico Sant'Orsola-Malpighi
Bologna, , Italy
Ospedale Brotzu
Cagliari, , Italy
Presidio Ospedaliero Sant'Elia
Caltanissetta, , Italy
University of Catania
Catania, , Italy
GVM Care and Research, E. S. Health Science Foundation
Cotignola, , Italy
Misericordia Hospital
Grosseto, , Italy
Ospedale Civile Ferdinando Veneziale
Isernia, , Italy
Policlinico G. Martino
Messina, , Italy
Centro Cardiologico Monzino IRCCS
Milan, , Italy
San Giovanni-Addolorata Hospital
Rome, , Italy
Università Cattolica Del Sacro Cuore
Rome, , Italy
Presidio Ospedaliero Umberto I°
Syracuse, , Italy
Central Clinical Hospital of the Ministry of Interior
Warsaw, , Poland
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Countries
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References
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Falk E, Shah PK, Fuster V. Coronary plaque disruption. Circulation. 1995 Aug 1;92(3):657-71. doi: 10.1161/01.cir.92.3.657. No abstract available.
De Caterina R. Endothelial dysfunctions: common denominators in vascular disease. Curr Opin Clin Nutr Metab Care. 2000 Nov;3(6):453-67. doi: 10.1097/00075197-200011000-00007.
Naghavi M, Libby P, Falk E, Casscells SW, Litovsky S, Rumberger J, Badimon JJ, Stefanadis C, Moreno P, Pasterkamp G, Fayad Z, Stone PH, Waxman S, Raggi P, Madjid M, Zarrabi A, Burke A, Yuan C, Fitzgerald PJ, Siscovick DS, de Korte CL, Aikawa M, Juhani Airaksinen KE, Assmann G, Becker CR, Chesebro JH, Farb A, Galis ZS, Jackson C, Jang IK, Koenig W, Lodder RA, March K, Demirovic J, Navab M, Priori SG, Rekhter MD, Bahr R, Grundy SM, Mehran R, Colombo A, Boerwinkle E, Ballantyne C, Insull W Jr, Schwartz RS, Vogel R, Serruys PW, Hansson GK, Faxon DP, Kaul S, Drexler H, Greenland P, Muller JE, Virmani R, Ridker PM, Zipes DP, Shah PK, Willerson JT. From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part I. Circulation. 2003 Oct 7;108(14):1664-72. doi: 10.1161/01.CIR.0000087480.94275.97.
Narula J, Nakano M, Virmani R, Kolodgie FD, Petersen R, Newcomb R, Malik S, Fuster V, Finn AV. Histopathologic characteristics of atherosclerotic coronary disease and implications of the findings for the invasive and noninvasive detection of vulnerable plaques. J Am Coll Cardiol. 2013 Mar 12;61(10):1041-51. doi: 10.1016/j.jacc.2012.10.054.
Jang IK, Bouma BE, Kang DH, Park SJ, Park SW, Seung KB, Choi KB, Shishkov M, Schlendorf K, Pomerantsev E, Houser SL, Aretz HT, Tearney GJ. Visualization of coronary atherosclerotic plaques in patients using optical coherence tomography: comparison with intravascular ultrasound. J Am Coll Cardiol. 2002 Feb 20;39(4):604-9. doi: 10.1016/s0735-1097(01)01799-5.
Jang IK, Tearney GJ, MacNeill B, Takano M, Moselewski F, Iftima N, Shishkov M, Houser S, Aretz HT, Halpern EF, Bouma BE. In vivo characterization of coronary atherosclerotic plaque by use of optical coherence tomography. Circulation. 2005 Mar 29;111(12):1551-5. doi: 10.1161/01.CIR.0000159354.43778.69. Epub 2005 Mar 21.
Kawasaki M, Bouma BE, Bressner J, Houser SL, Nadkarni SK, MacNeill BD, Jang IK, Fujiwara H, Tearney GJ. Diagnostic accuracy of optical coherence tomography and integrated backscatter intravascular ultrasound images for tissue characterization of human coronary plaques. J Am Coll Cardiol. 2006 Jul 4;48(1):81-8. doi: 10.1016/j.jacc.2006.02.062. Epub 2006 Jun 9.
Biccire FG, Fabbiocchi F, Gatto L, La Manna A, Ozaki Y, Romagnoli E, Marco V, Boi A, Fineschi M, Piedimonte G, Cerrato E, Musto C, Taglieri N, Di Giorgio A, Vizzari G, Ruscica G, Canova PA, Vergallo R, Burzotta F, Limbruno U, Albertucci M, Raber L, Crea F, Alfonso F, Arbustini E, Stone GW, Prati F. Long-Term Prognostic Impact of OCT-Derived High-Risk Plaque Features: Extended Follow-Up of the CLIMA Study. JACC Cardiovasc Interv. 2025 Jun 9;18(11):1361-1372. doi: 10.1016/j.jcin.2025.04.044.
Budassi S, Biccire FG, Gatto L, Scorza M, Marco V, Porta Y, Sammartini E, Paoletti G, Debelak C, Di Pietro R, Circhetta S, Albertucci M, Burzotta F, Ozaki Y, Canova PA, Piedimonte G, Alfonso F, Arbustini E, Prati F. Independent role of atherosclerotic plaque composition and extension in predicting the risk of cardiac events: a CLIMA substudy. Int J Cardiovasc Imaging. 2024 Dec;40(12):2535-2543. doi: 10.1007/s10554-024-03260-2. Epub 2024 Oct 21.
Biccire FG, Debelak C, Varricchione G, Budassi S, Gatto L, Romagnoli E, Di Pietro R, Sammartini E, Marco V, Paoletti G, Burzotta F, Ozaki Y, Pastori D, Alfonso F, Arbustini E, Prati F. Sex-specific features of optical coherence tomography detected plaque vulnerability related to clinical outcomes: insights from the CLIMA study. Int J Cardiovasc Imaging. 2023 Apr;39(4):873-881. doi: 10.1007/s10554-022-02775-w. Epub 2022 Dec 19.
Other Identifiers
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CLI-01-2013
Identifier Type: -
Identifier Source: org_study_id