Association Between IVUS and OCT Parameters and Invasive Physiologic Indices

Ischemic Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03795714
• Other study ID #: IVUS2017-11-056-001
• Status: Recruiting
• Start date: November 17, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: January 2019
• Source: Seoul National University Hospital
• Contact: Joo Myung Lee, MD, MPH, PhD
• Phone: 82-10-8884-8439
• Email: drone80[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• IVUS or OCT and Invasive physiologic indices
IVUS or OCT measurement in order to evaluate the lesion morphology and stent optimization, and invasive physiologic measurement in order to functional significance of epicardial stenosis

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by fractional flow reserve (FFR)	Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Primary	Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by instantaneous wave-free ratio (iFR)	Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by diastolic pressure ratio (dPR)	Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by resting full-cycle ratio (RFR)	Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR	Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Primary	Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR	Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR	Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR	Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR	Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Primary	Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR	Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR	Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR	Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR	Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Primary	Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by iFR	Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by iFR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by dPR	Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by dPR =0.89	During Cardiac Cath
Primary	Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR	Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Secondary	Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR	Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Secondary	Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR	Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Secondary	Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR	Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Secondary	Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR	Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Secondary	Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR	Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Secondary	Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR	Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Secondary	Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR	Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Secondary	Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR	Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Secondary	Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR	Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Secondary	Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR	Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Secondary	Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR	Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Secondary	Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR	Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Secondary	Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR	Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Secondary	Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR	Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Secondary	Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR	Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Secondary	Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR	Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Secondary	Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR	Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Secondary	Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR	Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Secondary	Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR	Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Secondary	Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR	Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Secondary	Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR	Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Secondary	Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR	Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Secondary	Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR	Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Secondary	Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR	Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Secondary	Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR	Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Secondary	Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR	Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Secondary	Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR	Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Secondary	Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR	Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Secondary	Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR	Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR =0.80	During Cardiac Cath
Secondary	Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR	Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR =0.89	During Cardiac Cath
Secondary	Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR	Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR =0.89	During Cardiac Cath
Secondary	Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR	Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR =0.89	During Cardiac Cath
Secondary	Linear correlation between percent diameter stenosis and FFR	Linear regression analysis between percent diameter stenosis and FFR	During Cardiac Cath
Secondary	Linear correlation between percent diameter stenosis and iFR	Linear regression analysis between percent diameter stenosis and iFR	During Cardiac Cath
Secondary	Linear correlation between percent diameter stenosis and dPR	Linear regression analysis between percent diameter stenosis and dPR	During Cardiac Cath
Secondary	Linear correlation between percent diameter stenosis and RFR	Linear regression analysis between percent diameter stenosis and RFR	During Cardiac Cath
Secondary	Linear correlation between minimal lumen diameter and FFR	Linear regression analysis between minimal lumen diameter and FFR	During Cardiac Cath
Secondary	Linear correlation between minimal lumen diameter and iFR	Linear regression analysis between minimal lumen diameter and iFR	During Cardiac Cath
Secondary	Linear correlation between minimal lumen diameter and dPR	Linear regression analysis between minimal lumen diameter and dPR	During Cardiac Cath
Secondary	Linear correlation between minimal lumen diameter and RFR	Linear regression analysis between minimal lumen diameter and RFR	During Cardiac Cath
Secondary	Linear correlation between minimal lumen area and FFR	Linear regression analysis between minimal lumen area and FFR	During Cardiac Cath
Secondary	Linear correlation between minimal lumen area and iFR	Linear regression analysis between minimal lumen area and iFR	During Cardiac Cath
Secondary	Linear correlation between minimal lumen area and dPR	Linear regression analysis between minimal lumen area and dPR	During Cardiac Cath
Secondary	Linear correlation between minimal lumen area and RFR	Linear regression analysis between minimal lumen area and RFR	During Cardiac Cath
Secondary	Linear correlation between plaque burden and FFR	Linear regression analysis between plaque burden and FFR	During Cardiac Cath
Secondary	Linear correlation between plaque burden and iFR	Linear regression analysis between plaque burden and iFR	During Cardiac Cath
Secondary	Linear correlation between plaque burden and dPR	Linear regression analysis between plaque burden and dPR	During Cardiac Cath
Secondary	Linear correlation between plaque burden and RFR	Linear regression analysis between plaque burden and RFR	During Cardiac Cath
Secondary	Discriminatory function of percent diameter stenosis to predict functional significance assessed by FFR	Discriminatory function of percent diameter stenosis to predict functional significance defined by FFR=0.80	During Cardiac Cath
Secondary	Discriminatory function of percent diameter stenosis to predict functional significance assessed by iFR	Discriminatory function of percent diameter stenosis to predict functional significance defined by iFR=0.89	During Cardiac Cath
Secondary	Discriminatory function of percent diameter stenosis to predict functional significance assessed by dPR	Discriminatory function of percent diameter stenosis to predict functional significance defined by dPR=0.89	During Cardiac Cath
Secondary	Discriminatory function of percent diameter stenosis to predict functional significance assessed by RFR	Discriminatory function of percent diameter stenosis to predict functional significance defined by RFR=0.89	During Cardiac Cath
Secondary	Discriminatory function of minimal lumen diameter to predict functional significance assessed by FFR	Discriminatory function of minimal lumen diameter to predict functional significance defined by FFR=0.80	During Cardiac Cath
Secondary	Discriminatory function of minimal lumen diameter to predict functional significance assessed by iFR	Discriminatory function of minimal lumen diameter to predict functional significance defined by iFR=0.89	During Cardiac Cath
Secondary	Discriminatory function of minimal lumen diameter to predict functional significance assessed by dPR	Discriminatory function of minimal lumen diameter to predict functional significance defined by dPR=0.89	During Cardiac Cath
Secondary	Discriminatory function of minimal lumen diameter to predict functional significance assessed by RFR	Discriminatory function of minimal lumen diameter to predict functional significance defined by RFR=0.89	During Cardiac Cath
Secondary	Discriminatory function of minimal lumen area to predict functional significance assessed by FFR	Discriminatory function of minimal lumen area to predict functional significance defined by FFR=0.80	During Cardiac Cath
Secondary	Discriminatory function of minimal lumen area to predict functional significance assessed by iFR	Discriminatory function of minimal lumen area to predict functional significance defined by iFR=0.89	During Cardiac Cath
Secondary	Discriminatory function of minimal lumen area to predict functional significance assessed by dPR	Discriminatory function of minimal lumen area to predict functional significance defined by dPR=0.89	During Cardiac Cath
Secondary	Discriminatory function of minimal lumen area to predict functional significance assessed by RFR	Discriminatory function of minimal lumen area to predict functional significance defined by RFR=0.89	During Cardiac Cath
Secondary	Discriminatory function of plaque burden to predict functional significance assessed by FFR	Discriminatory function of plaque burden to predict functional significance defined by FFR=0.80	During Cardiac Cath
Secondary	Discriminatory function of plaque burden to predict functional significance assessed by iFR	Discriminatory function of plaque burden to predict functional significance defined by iFR=0.89	During Cardiac Cath
Secondary	Discriminatory function of plaque burden to predict functional significance assessed by dPR	Discriminatory function of plaque burden to predict functional significance defined by dPR=0.89	During Cardiac Cath
Secondary	Discriminatory function of plaque burden to predict functional significance assessed by RFR	Discriminatory function of plaque burden to predict functional significance defined by RFR=0.89	During Cardiac Cath