Home > Research > Clinical Research Coordinating Center (CRCC) > Core Laboratories |
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 The
Cardiovascular Core Laboratories at the Clinical Research Coordinating
Center (CRCC) of CVRF is an academic cardiovascular imaging Core Lab which
provides internationally recognized expertise in an efficient and responsive
environment. The Core Labs provides the result of an unbiased interpretation
about pharmaceutical or mechanical intervention in coronary artery disease
and cardiac transplant studies. The independent processes reduce interobserver
or interobserver variability and increase the accuracy and precision of
results. Also the Core Labs will ensure that the investigators are adequately
trained to optimize the yield of the imaging data and to see that all
regulatory requirements are in place. It also will assist with data analysis
and interpretation, presentations to the medical community and education
of the regulatory agencies about the study results.
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 The tasks of
the Core Laboratories |
• GCP guideline compliant
• Protocol design
of phase III and IV studies
• Case report form design
• Data collection and Interpretation
• Imaging analysis
of angiography and intravascular ultrasound
• Data report
• Data analysis collaborated with data management center
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Education for physicians, technicians and nurses
• Collaborations
with important core laboratories and data centers |
 Quantitative
Coronary Angiographic (QCA) Core Laboratory |
| Young-Hak Kim, MD, PhD |
The QCA Core Lab exploits and adjusts catheterization and other procedure
imaging protocols for each clinical trial and project. It achieves perfect
and elaborate analysis of data for patients and clinical trial research.
These accomplishments are based on ceaseless attempts, aiming at perfection.
The Core Lab has experience in providing analysis for clinical studies
of percutaneous coronary or peripheral interventions with stent, angioplasty,
new coronary devices, and interventions with concomitant drug therapy.
Importantly, the Core Lab is dedicated to the collection of data on TIMI
grading and frame counting, morphology assessments for AHA/ACC lesion
classification, Quantitative Coronary Angiography (QCA), including minimum
lesion diameter, maximum percent diameter and area stenosis, normal (reference)
vessel diameters and lesion length, left-ventricular ejection fraction
and regional wall motion results, and ventricular volume indices.
Together with interdisciplinary collaborations and consultations, QCA
Core Lab provides unique and timely opportunities in interpreting the
results of clinical trials and managing clinical researches.
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Facilities |
• Research laboratory room
• Plain QCA software:
Pie Medical Corp, CASS-5
• Dedicated bifurcation angiographic
analysis software
• Angiographers |
Publicized
Research studies |
• Series of Long-DES Trials: Long-DES I, II, III
• Series of DECLARE Trials: DECLARE-DM, DECLARE-Long
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Series of ZEST Trials: ZEST, ZEST-AMI
• Bifurcation Trials:
CROSS, PERFECT
• Angiographic Follow-up Study: DES Follow-Up
• Study for Diabetics: ESSESNCE
• Prevention of
Nephropathy: PREVENT
• MAIN-COMPARE Registry |
| Intravascular
Ultrasound (IVUS) Core Laboratory |
| Myeong-Ki Hong, MD, PhD, Duk Woo Park,
MD, PhD |
The IVUS Core Lab offers a non-distortion analysis and conclusion of the
data, as recorded ultrasonographically. The IVUS Core Lab contains sophisticated
computer imaging equipment and analysis workstations designed specifically
for qualitative and quantitative coronary and peripheral ultrasound analyses.
It increases accuracy and reproducibility of interpreted results by decreasing
interobserver variability through consistent training and systematic analytical
processes. The IVUS Lab has experience in providing intravascular ultrasound
analysis for clinical studies in the area of atheroma progression/ regression,
various interventional techniques, transplant vasculopathy, quantitative
IVUS analysis, plaque morphology, stent optimization, and quantitative
and qualitative analysis for predicting the outcome of percutaneous coronary
intervention.
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Facilities |
• Research laboratory room
• IVUS hardware:
GalexyTM2 IVUS Imaging System
• IVUS software: INDECSystems,
EchoPlaque 2 software
• Virtual-histology IVUS (VH-IVUS) hardware:
Volcano VH IVUS System
• Optical coherence tomography (OCT):
LightLab OCT Imaging System
• Echocardiographer |
Publicized
Research studies |
• Plaque Regression and Progression Study : Statin trials:
STABLE trial
• VH IVUS and OCT Clinical Research : AMC registry
• Volumetric Analysis of Stent Trial
• Series
of Long-DES Trials: I, II, III
• Series of DECLARE Trials:
DECLARE-DM, DECLARE-Long
• Series of ZEST Trials: ZEST, ZEST-AMI
• Bifurcation Trials: CROSS, PERFECT
• Follow-up
Study: DES Follow-Up
• Stent trials: ESSESNCE |
| OCT/VH-IVUS
Imaging Center |
| Duk Woo Park, MD, PhD |
 The
VH IVUS system is a technology to enable real time (in the cardiac catheterization
lab) compositional assessment of atherosclerotic plaques in coronary arteries.
The VH IVUS technology uses advanced spectral analysis techniques to allow
simplified interpretation of ultrasound images and provides detailed information
on the composition of each patient's atherosclerotic plaques. The colorized
VH images show four plaque component types: fibrous, fibro-fatty, dense
calcium, and necrotic core. This novel technology provides automated measurement
tools to simplify image interpretation and employs a predetermined color
key to display plaque composition at a specific point in the artery or
across a region of interest. Recently, there has been significant interest
in the field of Vulnerable Plaque (VP) detection using OCT. OCT is an
imaging tool that permits high-resolution imaging (10-20 ¥ìm), in the vicinity
of 10 times greater than IVUS and has become a key tool to detect and
quantify thin cap fibroatheroma and macrophage distribution. This individual
clinical observation supports the evidence and clue for detection of vulnerability
for rupture.
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