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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02883088
Recruitment Status : Unknown
Verified December 2017 by Francesco Prati, San Giovanni Addolorata Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 30, 2016
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Information provided by (Responsible Party):
Francesco Prati, San Giovanni Addolorata Hospital

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.

Condition or disease Intervention/treatment
Coronary Artery Disease 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;

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1003 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Relationship Between Coronary Plaque Morphology of Left Anterior Descending Artery and Long Term Clinical Outcome: the CLIMA Study
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : December 1, 2016
Estimated Study Completion Date : December 1, 2019

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




Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 1-year ]
    Composite of cardiac death and/or target vessel myocadial infarction


Secondary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 3-year ]
    Composite of cardiac death and/or target vessel myocadial infarction


Other Outcome Measures:
  1. Predictive value of single OCT criteria of plaque vulnerability [ Time Frame: 1-year and 3-year ]
    Predictive value of minimum lumen area, fibrous cap thickness, lipid arc extension, presence of macrophages at the explored plaques



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883088


Locations
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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, Italy
Poland
Central Clinical Hospital of the Ministry of Interior
Warsaw, Poland
Spain
Hospital Universitario Clinico San Carlos
Madrid, Spain
Sponsors and Collaborators
San Giovanni Addolorata Hospital
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Investigators
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Principal Investigator: Francesco Prati, MD San Giovanni Addolorata Hospital
Additional Information:

Publications:
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.

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Responsible Party: Francesco Prati, Dr., San Giovanni Addolorata Hospital
ClinicalTrials.gov Identifier: NCT02883088    
Other Study ID Numbers: CLI-01-2013
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco Prati, San Giovanni Addolorata Hospital:
Optical coherence tomograhpy
registry
Coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases