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| Name | Class |
|---|---|
| Centro per la Lotta Contro l'Infarto - Fondazione Onlus | OTHER |
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The multicenter observational CLIMA registry has been conceived to explore correlation between OCT morphology of atherosclerotic plaques located in the left anterior descending artery with mid and long term clinical outcome.
Acute myocardial infarction (MI) is commonly caused by plaque ulceration and subsequent local thrombosis. Plaques that tend to rupture are typically characterized by a large superficial lipid pool, delimited by a thin fibrous cap and often exhibit local signs of inflammation. Such atherosclerotic lesions are commonly described as vulnerable plaques (1-4).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frequency Domain - Optical Coherence Tomography (FD-OCT) | Procedure | FD-OCT assessment of the native proximal-mid left descending artery during clinically indicated coronary angiography |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | Composite of cardiac death and/or target vessel myocadial infarction | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | Composite of cardiac death and/or target vessel myocadial infarction | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive value of single OCT criteria of plaque vulnerability | Predictive value of minimum lumen area, fibrous cap thickness, lipid arc extension, presence of macrophages at the explored plaques | 1-year and 3-year |
Inclusion Criteria:
Exclusion Criteria:
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All consecutive subjects undergoing OCT assessment of the proximal left descending artery coronary during coronary angiography should be screened for eligibility.
Patients will be enrolled from participating centers at the time of OCT assessment and prospectively investigated to evaluate clinical outcome.
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Prati, MD | San Giovanni Addolorata Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Sant'Orsola-Malpighi | Bologna | Italy | ||||
| Ospedale Brotzu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7634481 | Background | 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. | |
| 11085831 | Background | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| 14530185 | Background | 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. |
| 23473409 | Background | 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. |
| 11849858 | Background | 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. |
| 15781733 | Background | 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. |
| 16814652 | Background | 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. |
| 42297530 | Derived | Biccire FG, Arbustini E, Ozaki Y, Fabbiocchi F, Limbruno U, Gatto L, Romagnoli E, Kakizaki R, Preti G, Turturo M, Di Vito L, Cesaro A, Calabro P, Alfonso F, Farcomeni A, Antuna P, Papafaklis MI, Raber L, Prati F. Long-term prognostic impact of optical coherence tomography detected plaque rupture in nonculprit coronary segments. Atherosclerosis. 2026 Jun;417:120681. doi: 10.1016/j.atherosclerosis.2026.120681. Epub 2026 Jun 15. |
| 40500004 | Derived | 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. |
| 39432135 | Derived | 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. |
| 36534217 | Derived | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |