Relationship Between OCT Coronary Plaque Morphology and Clinical Outcome

NCT02883088 | Unknown DMC

• 1 other identifier: CLI-01-2013
• Study Type: observational
• Target: 1,003
• Locations: 3 countries
• Sites: 14

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.

Conditions

Coronary Artery Disease

Keywords

Optical coherence tomograhpy; registry; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events

  Composite of cardiac death and/or target vessel myocadial infarction

  1-year

Secondary Outcomes (1)

• Major adverse cardiac events

  3-year

Other Outcomes (1)

• Predictive value of single OCT criteria of plaque vulnerability

  1-year and 3-year

Study Arms (1)

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)

Interventions

Frequency Domain - Optical Coherence Tomography (FD-OCT) PROCEDURE

FD-OCT assessment of the native proximal-mid left descending artery during clinically indicated coronary angiography

LAD-group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• San Giovanni Addolorata Hospital: lead
• Centro per la Lotta Contro l'Infarto - Fondazione Onlus: collaborator

Study Sites (14)

Policlinico Sant'Orsola-Malpighi

Bologna, Italy

Location

Ospedale Brotzu

Cagliari, Italy

Location

Presidio Ospedaliero Sant'Elia

Caltanissetta, Italy

Location

University of Catania

Catania, Italy

Location

GVM Care and Research, E. S. Health Science Foundation

Cotignola, Italy

Location

Misericordia Hospital

Grosseto, Italy

Location

Ospedale Civile Ferdinando Veneziale

Isernia, Italy

Location

Policlinico G. Martino

Messina, Italy

Location

Centro Cardiologico Monzino IRCCS

Milan, Italy

Location

San Giovanni-Addolorata Hospital

Rome, Italy

Location

Università Cattolica Del Sacro Cuore

Rome, Italy

Location

Presidio Ospedaliero Umberto I°

Syracuse, Italy

Location

Central Clinical Hospital of the Ministry of Interior

Warsaw, Poland

Location

Hospital Universitario Clinico San Carlos

Madrid, Spain

Location

Related Publications (10)

• 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.

  PMID: 7634481 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.

  PMID: 11085831 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.

  PMID: 14530185 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.

  PMID: 23473409 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.

  PMID: 11849858 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.

  PMID: 15781733 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.

  PMID: 16814652 BACKGROUND

• 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.

  PMID: 40500004 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.

  PMID: 39432135 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.

  PMID: 36534217 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Francesco Prati, MD

  San Giovanni Addolorata Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2019
• Last Updated: December 21, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (12); PL (1)