Clinical trial NCT02883088: Relationship Between OCT Coronary Plaque Morphology and Clinical Outcome
Official title: Relationship Between Coronary Plaque Morphology of Left Anterior Descending Artery and Long Term Clinical Outcome: the CLIMA Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Optical coherence tomograhpy
registry
Coronary artery disease
Lead sponsor: San Giovanni Addolorata Hospital
Sponsor class: OTHER
Collaborators: name: Centro per la Lotta Contro l'Infarto - Fondazione Onlus
First posted: 2016-08-30
Enrollment: 1003
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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:

* minimum lumen area (MLA) \<3.5 mm2:
* fibrous cap minimum thickness \<75 µm:
* lipid arc extension \>180°;
* presence of macrophages;

Eligibility criteria: Inclusion Criteria:

* Age \>18 years;
* 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:

* Female with childbearing potential or lactating;
* 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

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 1-year
Secondary outcomes:
measure: Major adverse cardiac events
timeFrame: 3-year
Other outcomes:
measure: Predictive value of single OCT criteria of plaque vulnerability
timeFrame: 1-year and 3-year
Locations:
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola-Malpighi
city: Cagliari
country: Italy
facility: Ospedale Brotzu
city: Caltanissetta
country: Italy
facility: Presidio Ospedaliero Sant'Elia
city: Catania
country: Italy
facility: University of Catania
city: Cotignola
country: Italy
facility: GVM Care and Research, E. S. Health Science Foundation
city: Grosseto
country: Italy
facility: Misericordia Hospital
city: Isernia
country: Italy
facility: Ospedale Civile Ferdinando Veneziale
city: Messina
country: Italy
facility: Policlinico G. Martino
city: Milano
country: Italy
facility: Centro Cardiologico Monzino IRCCS
city: Rome
country: Italy
facility: San Giovanni-Addolorata Hospital
city: Rome
country: Italy
facility: Università Cattolica Del Sacro Cuore
city: Siracusa
country: Italy
facility: Presidio Ospedaliero Umberto I°
city: Warsaw
country: Poland
facility: Central Clinical Hospital of the Ministry of Interior
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
Study officials:
affiliation: San Giovanni Addolorata Hospital
name: Francesco Prati, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.