Acute Coronary Syndrome Clinical Trial
Official title:
Registry Using IVUS and iMAP to Evaluate Atherosclerotic Coronary Plaque in Acute Coronary Syndromes
The iWONDER trial has the following objective:
To analyze the morphological, phenotypic and tissue characteristics of atherosclerotic
plaques angiographically considered "culprit" and "not-culprit" in patients undergoing
coronary angiography due to STEMI (ST-elevation myocardial infarction).
Coronary artery angiography (CA) is a two-dimensional silhouette of the arterial lumen from
a complex three dimensional vascular structure. This exam has several limitations already
well documented, including shortening of the vessel, overlapping images, intra and
inter-observer variability during the consideration of the severity of injuries. Besides, it
offers great limitations in the diagnosis of the composition of atherosclerotic plaque.
Furthermore, intravascular ultrasound (IVUS) provides a sensitive and reproducible measure
of the dimensions of the vessel and allows direct visualization of the vessel wall,
atherosclerotic plaque and arterial lumen. The utility of grayscale IVUS as prognostic tool
and as a guide in percutaneous coronary interventions (PCI) is well established. More
recently, IVUS has also provided new insights for safety and efficacy of drug eluting stent
(DES).
Advances in technology now allow IVUS to characterize the morphology and composition of
plaques. Specifically, the analysis of the IVUS wave frequency - beyond the interpretation
of wave lengths used in grayscale IVUS- enables in vivo analysis of atherosclerotic plaque
composition with high sensitivity and specificity. Although previous studies have reported
data using IVUS radiofrequency analysis, the use of a new modality (iMapTM, Boston
Scientific, Santa Clara, CA, USA) for characterization of atherosclerotic plaque is poorly
known.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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