Clinical Research Coordinating Center (CRCC)
The Clinical Research Coordinating Center (CRCC), directed by Dr. Seung-Jung Park and Dr. Duk-Woo Park, was opened in 2005 to develop an optimal model for evaluating the feasibility of clinical research in cooperation with domestic and international centers. The CRCC assists with questionnaire development, case report form design, implementation of study protocols, data management, data entry, and statistical/database/web-based programming. Its data management systems can be custom designed for each project, enabling the center to conduct more accurate analysis. The center also analyzes characteristics and patterns of patients with cardiovascular disease and directs the tool of clinical research exactly and efficiently, which is regarded as the most essential step for the derivation of useful data.
The CRCC has 3 academic cardiovascular imaging core laboratories providing internationally recognized expertise in the field. They provide a result of unbiased interpretation about pharmaceutical or mechanical intervention in coronary artery disease and cardiac transplant studies. Their Independent processes reduce inter-observer or intra-observer variability and increase theaccuracy and precision of results. Also, the core labs assist with data analysis, interpretation, presentations to medical communities and education of regulatory agencies about the study results.
QCA Core Lab carries out a perfect and elaborate analysis by exploiting catheterization and other procedures for imaging protocols. The QCA Core Lab provides the result of analysis for clinical studies of percutaneous coronary or peripheral interventions with stent, angioplasty, new coronary devices ,and interventions with concomitant drug therapy. The QCA Core Lab is also dedicated to the collection of data on TIMI grading and frame counting, morphology assessments for AHA/ACC lesion classification, 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, the QCA Core Lab provides unique and timely opportunities in interpreting the results of clinical trials and managing clinical researches.
- Research laboratory room
- Plain QCA software: Pie Medical Corp, CASS-5
- Dedicated bifurcation angiographic analysis software
IVUS Core Lab offers a non-distortion analysis of the data recorded by ultrasonography. The result of its analysis has been provided for clinical studies in the are 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. The IVUS Core Lab contains sophisticated computer imaging equipment and analysis workstations specifically designed for qualitative and quantitative coronary and peripheral ultrasound analyses. These facilities increase accuracy and reproducibility of interpreted results by decreasing inter-observer variability through consistent training and systematic analytical processes.
- 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
OCT, which permits high-resolution imaging (10-20 um) in the vicinity of 10 times greater than IVUS, 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. VHIVUS system is a technology to enable real-time compositional assessment of atherosclerotic plaques in coronary arteries. VHIVUS technology requires advanced spectral analysis techniques to simplify interpretation of ultrasound images and provide detailed information on the composition of each patient's atherosclerotic plaque. 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 pre-determined color key to display plaque composition at a specific point in the artery or across a region of interest.