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Clinical Trial Summary

1. to evaluate diagnostic accuracy and performance of IVUS-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices.

2. to explores the association between IVUS-derived plaque characteristics and invasive physiologic indices.


Clinical Trial Description

Given the inherent limitations of coronary angiography to depict the presence of functionally significant epicardial coronary stenosis and discrepancy between angiographic stenosis severity and the presence of myocardial ischemia, invasive physiologic indices such as fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) has been a standard method to guide decision of revascularization.

Intravascular ultrasound (IVUS) is an intracoronary imaging method able to provide information about lumen area, vessel area, plaque burden, and plaque characteristics that can be used for the guidance of revascularization procedure. Several previous studies explored the diagnostic performance of IVUS-defined quantitative parameters to predict functional significance defined by FFR, however, quantitative parameter derived from IVUS showed only moderate diagnostic accuracy and the optimal cut-off value of IVUS-derived minimal lumen area (MLA) or minimal lumen diameter (MLD) were varied according to the patient population, interrogated vessels, and the location of target lesions, suggesting limited clinical relevance of judging functional significance of target stenosis using IVUS alone. Nevertheless, the adoption rate of FFR-guided decision has been limited due to various reasons and intravascular image-guided decision has been still used in substantial proportion of the patients.

Recently, new resting pressure-derived indices including resting full-cycle ratio (RFR) or diastolic pressure ratio (dPR) have been introduced as other substitutes for iFR, which does not require administration of hyperemic agents, therefore, possess more convenient in daily practice. Recent study with the largest sample size demonstrated identical diagnostic property and prognostic implication among iFR, RFR, and dPR. As those resting pressure-derived indices might have more generalizability for daily practice, it is expected to raise the adoption rate of physiologic interrogation. Therefore, understanding the association between all the available physiologic indices and IVUS-derived quantitative and qualitative parameters might be important in clinical decision for patient who underwent invasive coronary angiography.

In this regard, the investigators sought to evaluate diagnostic accuracy and performance of IVUS-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices and further explores the association between IVUS-derived plaque characteristics and invasive physiologic indices. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03795714
Study type Observational
Source Seoul National University Hospital
Contact Joo Myung Lee, MD, MPH, PhD
Phone 82-10-8884-8439
Email drone80@hanmail.net
Status Recruiting
Phase
Start date November 17, 2017
Completion date March 31, 2019

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