Cardiac ultrasound is capable of providing robust information regarding cardiovascular structure and function, making it a critical element of cardiovascular clinical research. The American Society of Echocardiography's (ASE) recommendations for the use of echocardiography in clinical trials have already contributed to proposed national standards for imaging, and the society's new reference guide for academic imaging core labs will be a key resource for clinical research.

ASE has compiled a list of 20 academic labs in the U.S. and abroad that have specified that they have participated in at least one multicenter trial, either funded by the National Institutes of Health (NIH) or with data submitted to the U.S. Food and Drug Administration (FDA). "This directory of analysis laboratories is part of the society's ongoing effort to ensure the value of echocardiography in clinical research," explained ASE past president Pamela Douglas, MD, FASE, professor at Duke University and director of the Duke Clinical Research Institute (DCRI) Imaging Program. ASE is providing self-reported information on academic imaging core labs as a public service and resource for federal, commercial and societal trials. Identifying academic imaging core laboratories and creating a profile of research capabilities also are essential to support the ASE's ongoing work with the NIH and FDA to better integrate cardiovascular ultrasound into their regulatory activities and funding priorities.

A core lab provides specialized or standardized services as part of a pre-clinical or clinical trial, or application to regulatory agency. For echocardiography core labs, activities can include trial design, training of personnel, acquisition of images, image interpretation, measurements, data storage, and preparation of reports. Regulatory agencies require a core lab to demonstrate detailed operational procedures and quality assurance measures with adherence to good clinical practice (GCP), a broad term for acceptable standards for conducting clinical research. Inclusion in the reference guide does not necessarily serve as an endorsement by the ASE or verification of quality as the information on the lab was self-submitted.

ASE is interested in assuring that properly performed imaging is the standard in clinical trials. Draft guidance recently issued by the FDA to establish standards for using imaging as an endpoint in clinical trials draws heavily from ASE's 2009 expert consensus statement, "Echocardiographic Imaging in Clinical Trials: American Society of Echocardiography Standards for Echocardiography Core Laboratories." This and other best practice standards from ASE serve as resources for good laboratory and clinical practice and provide a framework for echocardiographic quality assessment and improvement. ASE's new Reference Guide for Academic Imaging Core Labs (those labs that conduct centralized research analysis for multicenter clinical trials outside of the clinical scenario) expands the Society's clinical research resources.

 Many prominent clinical trials, including STICH (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease; ClinicalTrials.gov identifier NCT00023595) and PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain; ClinicalTrials.gov identifier NCT01174550) are using echocardiography core labs to improve patient care in the future.  ASE wants to help researchers to use echo in their study designs and to increase awareness that there are core labs that can provide assistance.