Clinical trial NCT03795714: Association Between IVUS and OCT Parameters and Invasive Physiologic Indices
Official title: Intravascular Ultrasound and Optical Coherence Tomography-Defined Optimal Criteria and Plaque Characteristics for Defining the Functional Significance of Coronary Stenoses Using Resting and Hyperemic Physiologic Indices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Heart Disease
Keywords: Intravascular Ultrasound
Optical Coherence Tomography
Fractional Flow Reserve
Diastolic Pressure Ratio
Resting Full-Cycle Ratio
Ischemic Heart Disease
Instantaneous Wave-free Ratio
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
First posted: 2019-01-08
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment and invasive physiologic assessment.

Brief summary: 1. to evaluate diagnostic accuracy and performance of IVUS and OCT-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices.
2. to explores the association between intravascular imaging-derived plaque characteristics and invasive physiologic indices.

Detailed 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) and optical coherence tomography (OCT) are 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 intravascular imaging-defined quantitative parameters to predict functional significance defined by FFR, however, quantitative parameter derived from intravascular imaging showed only moderate diagnostic accuracy and the optimal cut-off value of intravascular imaging-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 intravascular imaging 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 intravascular imaging-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 intravascular imaging-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices and further explores the association between IVUS and OCT-derived plaque characteristics and invasive physiologic indices.

Eligibility criteria: Inclusion Criteria:

* Patients who suspected ischemic heart disease, and underwent invasive physiologic assessment and intravascular ultrasound

Exclusion Criteria:

* Cardiogenic shock
* Graft vessel
* In-stent restenosis

Primary outcomes:
measure: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by fractional flow reserve (FFR)
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by instantaneous wave-free ratio (iFR)
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by diastolic pressure ratio (dPR)
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by resting full-cycle ratio (RFR)
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
Secondary outcomes:
measure: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Linear correlation between percent diameter stenosis and FFR
timeFrame: During Cardiac Cath
measure: Linear correlation between percent diameter stenosis and iFR
timeFrame: During Cardiac Cath
measure: Linear correlation between percent diameter stenosis and dPR
timeFrame: During Cardiac Cath
measure: Linear correlation between percent diameter stenosis and RFR
timeFrame: During Cardiac Cath
measure: Linear correlation between minimal lumen diameter and FFR
timeFrame: During Cardiac Cath
measure: Linear correlation between minimal lumen diameter and iFR
timeFrame: During Cardiac Cath
measure: Linear correlation between minimal lumen diameter and dPR
timeFrame: During Cardiac Cath
measure: Linear correlation between minimal lumen diameter and RFR
timeFrame: During Cardiac Cath
measure: Linear correlation between minimal lumen area and FFR
timeFrame: During Cardiac Cath
measure: Linear correlation between minimal lumen area and iFR
timeFrame: During Cardiac Cath
measure: Linear correlation between minimal lumen area and dPR
timeFrame: During Cardiac Cath
measure: Linear correlation between minimal lumen area and RFR
timeFrame: During Cardiac Cath
measure: Linear correlation between plaque burden and FFR
timeFrame: During Cardiac Cath
measure: Linear correlation between plaque burden and iFR
timeFrame: During Cardiac Cath
measure: Linear correlation between plaque burden and dPR
timeFrame: During Cardiac Cath
measure: Linear correlation between plaque burden and RFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of percent diameter stenosis to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of percent diameter stenosis to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of percent diameter stenosis to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Discriminatory function of percent diameter stenosis to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of minimal lumen diameter to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of minimal lumen diameter to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of minimal lumen diameter to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Discriminatory function of minimal lumen diameter to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of minimal lumen area to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of minimal lumen area to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of minimal lumen area to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Discriminatory function of minimal lumen area to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of plaque burden to predict functional significance assessed by FFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of plaque burden to predict functional significance assessed by iFR
timeFrame: During Cardiac Cath
measure: Discriminatory function of plaque burden to predict functional significance assessed by dPR
timeFrame: During Cardiac Cath
measure: Discriminatory function of plaque burden to predict functional significance assessed by RFR
timeFrame: During Cardiac Cath
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Professor
name: Bon-Kwon Koo, MD, PhD
role: STUDY_CHAIR
affiliation: Assistant Professor
name: Joo Myung Lee, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JM, Choi KH, Koo BK, Zhang J, Han JK, Yang HM, Park KW, Song YB, Hahn JY, Choi SH, Gwon HC, Kim HS. Intravascular ultrasound or optical coherence tomography-defined anatomic severity and hemodynamic severity assessed by coronary physiologic indices. Rev Esp Cardiol (Engl Ed). 2020 Oct;73(10):812-821. doi: 10.1016/j.rec.2019.11.001. Epub 2019 Dec 4. English, Spanish.