For nearly two decades, our Core Laboratories have placed CRF at the forefront of cardiovascular research by constantly refining and standardizing our methodology and ability to interpret enormous quantities of data from countless clinical trials and research studies. Similarly, our Data Coordinating Center has been a major leader in the field, providing a full spectrum of clinical trial management services. With a global database noted for its size and scope and its advanced IT platform, the Data Center has been able to track the long-term safety and efficacy of emerging techniques and treatments, allowing us to promptly answer questions related to newer technologies entering clinical practice.
With the merging of our Core Laboratories and Data Coordination Center, the new CTC has raised the bar, offering a stronger, broader, and more unified effort in evaluating the therapies of tomorrow.
The Angiographic Core Laboratory
The Angiographic Core Laboratory specializes in the analysis of coronary and peripheral angiograms. Since its founding in 1991, the Angiographic Core Laboratory has developed and validated a broad range of quantitative and qualitative tools and methods, assessing and benchmarking device effectiveness, developing models to better understand short- and long-term outcomes, and evaluating mechanistic insights into treatment outcomes for a wide range of interventional devices and pharmacologic trials.
Our CTC Angiographic Core Laboratory has undertaken over 50 Investigational Device Exemption (IDE) trials including new devices, 1st to 4th generation stents, primary angioplasty, vascular brachytherapy, and drug-eluting stents. Thanks to the precision of our interpretive models and procedures, many of these devices and techniques have been proven to be safe and effective and now figure prominently in everyday interventional cardiology practices.
The Multidetector Computed Tomographic Angiography Core Laboratory
The Multidetector Computed Tomographic Angiography Core Laboratory uses state-of-the-art software to validate and standardize the analytic methodology for CTA, working in close collaboration with our team of world-renowned experts in quantitative coronary angiography and intravascular ultrasound.
Multidetector computed tomographic angiography is a noninvasive imaging technique that analyzes the cardiac structures based on their X-ray density profile. Its main application includes the assessment of native coronary artery stenosis, restenosis, atherosclerotic burden, and plaque densitometry characterization.
The Intravascular Imaging Core Laboratory
The Intravascular Imaging Core Laboratory provides independent and expert quantitative and qualitative intravascular ultrasound (IVUS), virtual histology IVUS, and optical coherence tomography (OCT) assessment for coronary device, pharmacologic, and regression trials, and has performed pioneering work in the emerging field of vulnerable plaque.
Intravascular Ultrasound (IVUS) provides a tomographic image of the coronary artery that allows direct measurements of plaque, stent, lumen cross-sectional areas, and volumes, and provides insight into the mechanisms and degrees of restenosis. IVUS is also useful for assessing plaque progression and regression. The IVUS Core Laboratory is currently conducting multiple analyses for large pivotal trials in a broad range of clinical settings and of various new devices.
Virtual Histology (VH-IVUS) extends the information provided by standard grayscale IVUS to include quantitative tissue characterization that has the potential for detecting vulnerable (thrombosis-prone) plaques as well as plaque stabilization induced pharmacologically. For the last four years, virtual histology has been central in the evaluation and identification of vulnerable plaques.
Optical Coherence Tomography (OCT) uses light rather than ultrasound to image the coronary arteries. OCT has ten times the resolution of IVUS (but less tissue penetration) to provide more precise surface information such as thin-cap fibroatheroma, tissue coverage of stent struts, thrombus formation, and stent malapposition. The OCT Core Laboratory has focused on the validation of this technology as well as its use in clinical trials as an important surrogate endpoint.
The Electrocardiography (ECG) Core Laboratory
The Electrocardiography (ECG) Core Laboratory is an integral part of our clinical research organization, supporting large-scale national and international trials by providing independent electrocardiographic interpretation. ECG data comprise a critical component of most clinical trials and studies. In fact, ECG data interpretation and analysis is required by the FDA for all device and drug development to identify effect, efficacy, safety, and tolerance. The ECG Core Laboratory provides electrocardiographic analysis, utilization, and interrelationship with other outcome variables. The ECG analysis, based on the protocol, will analyze ECG intervals, morphology, conduction, and rhythms using standard 12-lead ECG or long-rhythm analysis. The ECG Core Laboratory functions to support multifaceted as well as ECG-only protocols.
The Cardiac Magnetic Resonance Imaging (MRI) Core Laboratory
The Cardiac Magnetic Resonance Imaging (MRI) Core Laboratory reviews and analyzes cardiac MR images for clinical trials. Some of the parameters that can be assessed include global and regional systolic ventricular function, myocardial perfusion and viability, and valvular heart disease. The Cardiac MRI Core Laboratory provides both qualitative and quantitative analysis. Recent advances in the field have dramatically improved the quality of Cardiac MRI images by providing excellent spatial and temporal resolution and enough sensitivity to detect smaller areas of heart muscle damage with an accuracy that surpasses other forms of testing. With higher precision and reproducibility, MRI, as a surrogate endpoint, has the potential for allowing trials to reach statistical significance with fewer patients and reducing the time necessary to complete clinical trials.
CRF collaborates with the Columbia University Medical Center’s Echocardiographic Core Laboratory to provide expert detailed analyses of transthoracic, transesophageal, and intracardiac echocardiographic studies.
