NCT03795714

Brief Summary

  1. 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. 2.to explores the association between intravascular imaging-derived plaque characteristics and invasive physiologic indices.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

December 28, 2018

Last Update Submit

January 17, 2019

Conditions

Ischemic Heart Disease

Keywords

Intravascular UltrasoundOptical Coherence TomographyFractional Flow ReserveDiastolic Pressure RatioResting Full-Cycle RatioIschemic Heart DiseaseInstantaneous Wave-free Ratio

Outcome Measures

Primary Outcomes (16)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (64)

  • Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR

    During Cardiac Cath

  • Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR

    During Cardiac Cath

  • Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR

    During Cardiac Cath

  • Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR

    During Cardiac Cath

  • Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR

    During Cardiac Cath

  • +59 more secondary outcomes

Study Arms (1)

Intravascular Imaging and Physiologic Assessment

330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment and invasive physiologic assessment.

Diagnostic Test: IVUS or OCT and Invasive physiologic indices

Interventions

IVUS or OCT and Invasive physiologic indicesDIAGNOSTIC_TEST

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

Intravascular Imaging and Physiologic Assessment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment and invasive physiologic assessment.

You may qualify if:

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

You may not qualify if:

  • Cardiogenic shock
  • Graft vessel
  • In-stent restenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Seoul national university hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31812517DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Bon-Kwon Koo, MD, PhD

    Professor

    STUDY CHAIR

  • Joo Myung Lee, MD, MPH, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Myung Lee, MD, MPH, PhD

CONTACT

82-10-8884-8439drone80@hanmail.net

Ki Hong Choi, MD

CONTACT

82-10-8875-1648cardiokh@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2018

First Posted

January 8, 2019

Study Start

November 17, 2017

Primary Completion

January 31, 2019

Study Completion

March 31, 2019

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations

KR(2)