Contact: Rachel Cagan, rcagan@acc.org, 202-375-6395

WASHINGTON (Dec 29, 2014) -

The American College of Cardiology and the American Heart Association today released clinical data standards for cardiovascular and endpoints in clinical trials.

The document, which was developed in collaboration with the U.S. Food and Drug Administration and the Standardized Data Collection for Cardiovascular Trials Initiative, is the first step in developing a universal language to uniformly capture clinical event information across all types of clinical trials and other research and clinical evaluations. The data standards will facilitate the conduct of pooled analyses and meta-analyses to evaluate safety and effectiveness in clinical trials.  These data standards may also be used in clinical care processes, registries, electronic health records, longitudinal drug or device surveillance, and other types of health-related research to capture key cardiovascular outcomes. This unique collaboration acknowledges the need to align key clinical concepts for regulatory reporting and key concepts for clinical care. 

The 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials will publish in full today on the websites for the ACC (www.acc.org) and AHA (www.heart.org) and will appear in upcoming print editions of Journal of the American College of Cardiology and Circulation. 

About the American College of Cardiology

The American College of Cardiology is a 47,000-member medical society that serves as the professional home for the entire cardiovascular care team. The mission of the College is to transform cardiovascular care and to improve heart health. The ACC leads in the formation of health policy, clinical standards and practice guidelines. The College operates national registries to measure and improve care. It also provides professional medical education, disseminates cardiovascular research, and bestows credentials upon cardiovascular specialists who meet stringent qualifications. For more information, visit www.acc.org. 

About the American Heart Association

The American Heart Association is devoted to saving people from heart disease and stroke – America’s No. 1 and No. 4 killers. We team with millions of volunteers to fund innovative research, fight for stronger public health policies, and provide lifesaving tools and information to prevent and treat these diseases. The Dallas-based association is the nation’s oldest and largest voluntary organization dedicated to fighting heart disease and stroke. To learn more or to get involved, call 1-800-AHA-USA1, visit heart.org or call any of our offices around the country.  Follow us on Facebook and Twitter.

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