VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve

This study is currently recruiting participants.
Verified March 2013 by Inje University
Seoul National University Hospital
Information provided by (Responsible Party):
Joon Hyung Doh, Inje University
ClinicalTrials.gov Identifier:
First received: September 26, 2011
Last updated: March 16, 2013
Last verified: March 2013

Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS) is a useful test predicting clinical outcomes of the coronary artery disease (CAD). Thin cap fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by VH-IVUS combined with more than 70% plaque burden and less than 4mm² minimal lumen area (MLA) by IVUS. Fractional flow reserve (FFR) is an established index of the physiological significance of a coronary stenosis. Recent large scale trials demonstrated FFR guided PCI showed favorable clinical outcomes. VH-IVUS represents anatomical severity, but FFR represents functional severity of CAD. Few studies reported relevance between two tests. Aim of this study was to investigate whether the geometry and composition of lesions were different under FFR criteria.

Coronary Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Virtual Histology (VH)-Intravascular Ultrasound (IVUS) Tissue Characteristics Analysis of the Intermediate Coronary Artery Stenosis Lesion Predicting Physiologic Myocardial Ischemia by Myocardial Fraction Flow Reserve (FFR)

Resource links provided by NLM:

Further study details as provided by Inje University:

Primary Outcome Measures:
  • Differences VH-IVUS plaque composition between different FFR groups [ Time Frame: baseline ] [ Designated as safety issue: No ]
    VH-IVUS tissue composition (necrotic core, dense calicium, fibrotic, fibrofatty %) and atheroma type will be compared according to different FFR groups at the time of measurement procedure.

Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
low FFR group (<0.8)
the patient with FFR values less than 0.8
high FFR group (>0.8)
the patient with FFR values greater than 0.8


Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who underwent coronary angiography for the diagnostic purposes because of clinical angina pectoris. Patient who underwent simultaneous virtual histology-intravascular ultrasound (VH-IVUS)and fractional flow reserve (FFR) measurement at the time of coronary angiography would be enrolled consecutively.


Inclusion Criteria:

  • clinical angina pectoris who underwent VH-IVUS and FFR during coronary angiography.
  • agree with informed consent

Exclusion Criteria:

  • unable to get informed consent
  • low left ventricular ejection fraction less than 35%
  • chronic renal failure (Cr>2.0mg/dl)
  • acute myocardial infarction related coronary artery
  • allergy to adenosine injection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444599

Contact: Joon Hyung Doh, MD PhD 82-10-9610-1570 joon.doh@gmail.com

Korea, Republic of
Inje University Ilsan Paik Hospital Recruiting
Goyang, Gyeonggido, Korea, Republic of, 411-709
Contact: Joon Hyung Doh, MDPhD    82-31-910-7830    joon.doh@gmail.com   
Principal Investigator: Joon hyung Doh, MDPhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Bon-Kwon Koo, MDPhD       bkkoo@snu.ac.kr   
Principal Investigator: Bon-Kwon Koo, MDPhD         
Sponsors and Collaborators
Inje University
Seoul National University Hospital
Principal Investigator: Joon Hyung Doh, MDPhD Inje University
  More Information

Responsible Party: Joon Hyung Doh, Associate Professor of Medicine, Inje University
ClinicalTrials.gov Identifier: NCT01444599     History of Changes
Other Study ID Numbers: IB-1110-048
Study First Received: September 26, 2011
Last Updated: March 16, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Inje University:
coronary atherosclerosis
virtual histology intravascular ultrasound
fractional flow reserve

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Disease
Coronary Artery Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 17, 2014