Relationship Between OCT Coronary Plaque Morphology and Clinical Outcome (CLIMA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Frequency Domain - Optical Coherence Tomography (FD-OCT)

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;

• Study Type: Observational
• Enrollment (Actual): 1003

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • Policlinico Sant'Orsola-Malpighi
  • Cagliari, Italy
    • Ospedale Brotzu
  • Caltanissetta, Italy
    • Presidio Ospedaliero Sant'Elia
  • Catania, Italy
    • University of Catania
  • Cotignola, Italy
    • GVM Care and Research, E. S. Health Science Foundation
  • Grosseto, Italy
    • Misericordia Hospital
  • Isernia, Italy
    • Ospedale Civile Ferdinando Veneziale
  • Messina, Italy
    • Policlinico G. Martino
  • Milano, Italy
    • Centro Cardiologico Monzino IRCCS
  • Rome, Italy
    • Universita Cattolica del Sacro Cuore
  • Rome, Italy
    • San Giovanni-Addolorata Hospital
  • Siracusa, Italy
    • Presidio Ospedaliero Umberto I°
• Poland
  • Warsaw, Poland
    • Central Clinical Hospital of the Ministry of Interior
• Spain
  • Madrid, Spain
    • Hospital Universitario Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Procedure: Frequency Domain - Optical Coherence Tomography (FD-OCT); FD-OCT assessment of the native proximal-mid left descending artery during clinically indicated coronary angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events	Composite of cardiac death and/or target vessel myocadial infarction	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events	Composite of cardiac death and/or target vessel myocadial infarction	3-year

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: San Giovanni Addolorata Hospital
• Collaborators: Centro per la Lotta Contro l'Infarto - Fondazione Onlus
• Investigators: Principal Investigator: Francesco Prati, MD, San Giovanni Addolorata Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Coronary artery disease; registry; Optical coherence tomograhpy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CLI-01-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No