Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative

Alexandra J. Lansky, Steven R. Messé, Adam M. Brickman, Michael Dwyer, H. Bart van der Worp, Ronald M. Lazar, Cody G. Pietras, Kevin J. Abrams, Eugene McFadden, Nils H. Petersen, Jeffrey Browndyke, Bernard Prendergast, Vivian G. Ng, Donald E. Cutlip, Samir Kapadia, Mitchell W. Krucoff, Axel Linke, Claudia Scala Moy, Joachim Schofer, Gerrit Anne van EsRenu Virmani, Jeffrey Popma, Michael K. Parides, Susheel Kodali, Michel Bilello, Robert Zivadinov, Joseph Akar, Karen L. Furie, Daryl Gress, Szilard Voros, Jeffrey Moses, David Greer, John K. Forrest, David Holmes, Arie P. Kappetein, Michael Mack, Andreas Baumbach

Research output: Contribution to journalReview article

43 Scopus citations

Abstract

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Original languageEnglish (US)
Pages (from-to)679-691
Number of pages13
JournalJournal of the American College of Cardiology
Volume69
Issue number6
DOIs
StatePublished - Feb 14 2017

Keywords

  • cardiovascular
  • methodology
  • neurological definitions
  • outcomes
  • stroke
  • trials

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Lansky, A. J., Messé, S. R., Brickman, A. M., Dwyer, M., van der Worp, H. B., Lazar, R. M., Pietras, C. G., Abrams, K. J., McFadden, E., Petersen, N. H., Browndyke, J., Prendergast, B., Ng, V. G., Cutlip, D. E., Kapadia, S., Krucoff, M. W., Linke, A., Moy, C. S., Schofer, J., ... Baumbach, A. (2017). Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. Journal of the American College of Cardiology, 69(6), 679-691. https://doi.org/10.1016/j.jacc.2016.11.045