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June 13, 2026Journal of the American College of Cardiology608 citations

2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials

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KHKaren A. HicksJTJames E. TchengBBBiykem Bozkurt

Key Points

  • The aim is to provide standardized definitions and data elements for cardiovascular endpoint events in clinical trials.
  • Developed key definitions and data elements for cardiovascular events.
  • Engaged experts in cardiovascular research to ensure relevance.
  • Reviewed existing literature and guidelines for comprehensive coverage.
  • Established clear definitions for various cardiovascular endpoints.
  • Provided a comprehensive list of data elements needed for accurate reporting.
  • Facilitated improved consistency in cardiovascular clinical trial outcomes.

Abstract

No abstract was published with this document — society guidelines, consensus pathways, and scientific statements are typically released without one. See the Key Points and the linked PDF for the full content.

Expert Takes1 quote

“We developed a standardized vocabulary for documenting and reporting critical cardiovascular adverse events, along with specifications for the exchange of that information between computer systems. The key use will be in reporting findings to the FDA, whether in the context of clinical trials, pharmacovigilance, or device surveillance. Ultimately, we anticipate widespread adoption of this vocabulary throughout healthcare (including routine clinical care) as a catalyst for accelerating improvements in patient management and treatment.”

James Tcheng, Professor of Medicine, Duke Translational Medicine Instituteauto_pipelineSupportiveView source
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Cite This Study

Hicks et al. (2014) studied this question.

synapsesocial.com/papers/6a2d74fe8208756159c187a1https://doi.org/10.1016/j.jacc.2014.12.018
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