An observational study in Coronary Artery Disease, sponsored by San Giovanni Addolorata Hospital. Status unknown at 14 sites in 3 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-12-21.
Sponsored by San Giovanni Addolorata Hospital · Observational
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.
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:
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 1,003 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →San Giovanni Addolorata Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Major adverse cardiac events
Composite of cardiac death and/or target vessel myocadial infarction
Time frame: 1-year
Major adverse cardiac events
Composite of cardiac death and/or target vessel myocadial infarction
Time frame: 3-year
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
Time frame: 1-year and 3-year
Plan to share: No
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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San Giovanni Addolorata Hospital