NCT02883088

Relationship Between OCT Coronary Plaque Morphology and Clinical Outcome

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,003 (actual)
• Sponsor: San Giovanni Addolorata Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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;

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Frequency Domain - Optical Coherence Tomography (FD-OCT)	FD-OCT assessment of the native proximal-mid left descending artery during clinically indicated coronary angiography

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-12-01
• Completion: 2019-12-01
• First posted: 2016-08-30
• Last updated: 2017-12-21

Locations

14 sites across 3 countries: Italy, Poland, Spain