Relationship Between OCT Coronary Plaque Morphology and Clinical Outcome

Coronary Artery Disease Clinical Trial

— CLIMA  

Official title:

Relationship Between Coronary Plaque Morphology of Left Anterior Descending Artery and Long Term Clinical Outcome: the CLIMA Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02883088
• Other study ID #: CLI-01-2013
• Status: Active, not recruiting
• Phase: N/A
• First received: August 25, 2016
• Last updated: December 19, 2017
• Start date: January 1, 2013
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2017
• Source: San Giovanni Addolorata Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1003
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Frequency Domain - Optical Coherence Tomography (FD-OCT)
FD-OCT assessment of the native proximal-mid left descending artery during clinically indicated coronary angiography

Locations

Country	Name	City	State
Italy	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	Milano
Italy	San Giovanni-Addolorata Hospital	Rome
Italy	Università Cattolica Del Sacro Cuore	Rome
Italy	Presidio Ospedaliero Umberto I°	Siracusa
Poland	Central Clinical Hospital of the Ministry of Interior	Warsaw
Spain	Hospital Universitario Clinico San Carlos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
San Giovanni Addolorata Hospital	Centro per la Lotta contro l’Infarto – Fondazione Onlus

Countries where clinical trial is conducted

Italy,  Poland,  Spain, 

References & Publications (7)

De Caterina R. Endothelial dysfunctions: common denominators in vascular disease. Curr Opin Clin Nutr Metab Care. 2000 Nov;3(6):453-67. Review. — View Citation

Falk E, Shah PK, Fuster V. Coronary plaque disruption. Circulation. 1995 Aug 1;92(3):657-71. Review. — View 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. — View 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. Epub 2005 Mar 21. — View 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. Epub 2006 Jun 9. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Major adverse cardiac events	Composite of cardiac death and/or target vessel myocadial infarction	1-year
Secondary	Major adverse cardiac events	Composite of cardiac death and/or target vessel myocadial infarction	3-year