Core Laboratory Analysis and Committee Management

The Angiographic Core Laboratory provides independent quantitative and qualitative assessment of coronary, peripheral, neurovascular, and venous angiograms using validated endpoints.

The Echocardiographic Core Laboratory provides state-of-the-art echocardiographic imaging interpretation and analysis, with extensive experience in the evaluation of echocardiographic measures for national and international multi-center clinical trials.

Examples include:

• Assessment of cardiac structural and valvular morphology and function in a wide range of interventions
• Analytic measures critical to the evaluation of acute myocardial infarction in the context of clinical trials.

The Intravascular Imaging Core Laboratory provides state-of-the-art intravascular imaging interpretation and analysis, including the latest technologies in intravascular ultrasound, optical coherence tomography, and near-infrared spectroscopy. The team has extensive experience in the analysis of validated endpoints, as well as the development of novel analysis tools and metrics for the assessment of diagnostic and therapeutic intravascular technologies.

The Physiology Core Laboratory uses commercial and customized software solutions for high-quality and accurate assessment and interpretation of pressure-wired based epicardial coronary indices such as fractional flow reserve (FFR) and non-hyperemic pressure ratios (iFR, RFR, DFR, DPR, dPR), doppler and thermodilution coronary flow data, microcirculation indices, and computational processing of physiology based on angiographic (QFR, FR), intravascular ultrasound (UFR), and optical coherence tomography (OFR) images.

The Wound Core Laboratory provides standardized assessment of wound severity, dimensions, and healing to meet regulatory requirements for pivotal trials of peripheral arterial disease treatments.

The Yale Cardiovascular Research Group offers clinical events committee organization and implementation to independently adjudicate clinical events, conforming to regulatory requirements within single- or multicenter, national, or international clinical trials. YCRG works with trialists experienced in the full spectrum of cardiovascular disease who are familiar with contemporary scales and definitions common to a variety of drug and device clinical trials.

YCRG organizes and implements comprehensive data safety monitoring boards to ensure the ethical conduct of clinical trials to protect the rights and safety of enrolled patients. This includes:

• Documentation of all committee meetings
• Administrative and communication support between the sponsor, contract research organization, biostatistics, and data safety board members.