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)
1 other identifier
observational
100
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2010
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 26, 2011
CompletedFirst Posted
Study publicly available on registry
October 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 24, 2015
March 1, 2015
4.4 years
September 26, 2011
March 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences VH-IVUS plaque composition between different FFR groups
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.
baseline
Secondary Outcomes (2)
Serial physiologic and plaque composition changes of deferred lesions at 1 year FFR and VH-IVUS follow-up.
one year
Serial physiologic and plaque composition changes of stented lesions at 1 year FFR and VH-IVUS follow-up.
one year
Study Arms (2)
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 Criteria
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.
You may qualify if:
- clinical angina pectoris who underwent VH-IVUS and FFR during coronary angiography.
- agree with informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inje Universitylead
- Seoul National University Hospitalcollaborator
Study Sites (4)
Inje University Ilsan Paik Hospital
Goyang, Gyeonggido, 411-709, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Ulsan University Hospital
Ulsan, South Korea
Related Publications (3)
Brugaletta S, Garcia-Garcia HM, Shen ZJ, Gomez-Lara J, Diletti R, Sarno G, Gonzalo N, Wijns W, de Bruyne B, Alfonso F, Serruys PW. Morphology of coronary artery lesions assessed by virtual histology intravascular ultrasound tissue characterization and fractional flow reserve. Int J Cardiovasc Imaging. 2012 Feb;28(2):221-8. doi: 10.1007/s10554-011-9816-3. Epub 2011 Feb 19.
PMID: 21336551BACKGROUNDKubo T, Maehara A, Mintz GS, Doi H, Tsujita K, Choi SY, Katoh O, Nasu K, Koenig A, Pieper M, Rogers JH, Wijns W, Bose D, Margolis MP, Moses JW, Stone GW, Leon MB. The dynamic nature of coronary artery lesion morphology assessed by serial virtual histology intravascular ultrasound tissue characterization. J Am Coll Cardiol. 2010 Apr 13;55(15):1590-7. doi: 10.1016/j.jacc.2009.07.078.
PMID: 20378076BACKGROUNDStone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.
PMID: 21247313BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joon Hyung Doh, MDPhD
Inje University Ilsan Paik Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
September 26, 2011
First Posted
October 3, 2011
Study Start
March 1, 2010
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
March 24, 2015
Record last verified: 2015-03