VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Inje University
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by (Responsible Party):
Joon Hyung Doh, Inje University
ClinicalTrials.gov Identifier:
NCT01444599
First received: September 26, 2011
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition
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.


Secondary Outcome Measures:
  • Serial physiologic and plaque composition changes of deferred lesions at 1 year FFR and VH-IVUS follow-up. [ Time Frame: one year ] [ Designated as safety issue: No ]
    Approximately 60-70 of 100 enrolled patients would be deferred according to FFR values. Patient who provide consent for clinical and angiographic follow-up at one year would be assessed by physiologic FFR and VH-IVUS derived plaque composition. Relationship of serial physiologic and plaque composition changes will be evaluated. Anatomic and physiologic parameters associated with plaque progression and/or regression will be determined.

  • Serial physiologic and plaque composition changes of stented lesions at 1 year FFR and VH-IVUS follow-up. [ Time Frame: one year ] [ Designated as safety issue: No ]
    Approximately 30-40 of 100 enrolled patients would be stented according to FFR values. Patient who provide consent for clinical and angiographic follow-up at one year would be assessed by physiologic FFR and VH-IVUS derived plaque composition including stented segment. Relationship of serial physiologic and plaque composition changes will be evaluated. Anatomic and physiologic parameters associated with stent failure will be determined.


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444599

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

Locations
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         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Chang-Wook Nam, MD,PhD       namcwcv@gmail.com   
Principal Investigator: Chang-Wook Nam, MD,PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Bon-Kwon Koo, MDPhD       bkkoo@snu.ac.kr   
Principal Investigator: Bon-Kwon Koo, MDPhD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Eun-Seok Shin, MD,PhD       sesim1989@gmail.com   
Principal Investigator: Eun-Seok Shin, MD,PhD         
Sponsors and Collaborators
Inje University
Seoul National University Hospital
Investigators
Principal Investigator: Joon Hyung Doh, MDPhD Inje University
  More Information

Publications:
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: May 12, 2014
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014