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

September 26, 2011
May 12, 2014
March 2010
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01444599 on ClinicalTrials.gov Archive Site
  • 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.
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VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve
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)

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.

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Probability Sample

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.

Coronary Disease
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
Contact: Joon Hyung Doh, MD PhD 82-10-9610-1570 joon.doh@gmail.com
Korea, Republic of
 
NCT01444599
IB-1110-048
Yes
Joon Hyung Doh, Inje University
Inje University
Seoul National University Hospital
Principal Investigator: Joon Hyung Doh, MDPhD Inje University
Inje University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP