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 Es; Renu 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

doi:10.1016/j.jacc.2016.11.045

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 journal › Review article › peer-review

97 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 language	English (US)
Pages (from-to)	679-691
Number of pages	13
Journal	Journal of the American College of Cardiology
Volume	69
Issue number	6
DOIs	https://doi.org/10.1016/j.jacc.2016.11.045
State	Published - Feb 14 2017
Externally published	Yes

Keywords

cardiovascular
methodology
neurological definitions
outcomes
stroke
trials

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jacc.2016.11.045

Cite this

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

Lansky, AJ, Messé, SR, Brickman, AM, Dwyer, M, van der Worp, HB, Lazar, RM, Pietras, CG, Abrams, KJ, McFadden, E, Petersen, NH, Browndyke, J, Prendergast, B, Ng, VG, Cutlip, DE, Kapadia, S, Krucoff, MW, Linke, A, Moy, CS, Schofer, J, van Es, GA, Virmani, R, Popma, J, Parides, MK, Kodali, S, Bilello, M, Zivadinov, R, Akar, J, Furie, KL, Gress, D, Voros, S, Moses, J, Greer, D, Forrest, JK, Holmes, D, Kappetein, AP, Mack, M & Baumbach, A 2017, 'Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative', Journal of the American College of Cardiology, vol. 69, no. 6, pp. 679-691. https://doi.org/10.1016/j.jacc.2016.11.045

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title = "Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative",

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.",

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note = "Publisher Copyright: {\textcopyright} 2017 The Authors",

year = "2017",

month = feb,

day = "14",

doi = "10.1016/j.jacc.2016.11.045",

language = "English (US)",

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T2 - An Academic Research Consortium Initiative

AU - Lansky, Alexandra J.

AU - Messé, Steven R.

AU - Brickman, Adam M.

AU - Dwyer, Michael

AU - van der Worp, H. Bart

AU - Lazar, Ronald M.

AU - Pietras, Cody G.

AU - Abrams, Kevin J.

AU - McFadden, Eugene

AU - Petersen, Nils H.

AU - Browndyke, Jeffrey

AU - Prendergast, Bernard

AU - Ng, Vivian G.

AU - Cutlip, Donald E.

AU - Kapadia, Samir

AU - Krucoff, Mitchell W.

AU - Linke, Axel

AU - Moy, Claudia Scala

AU - Schofer, Joachim

AU - van Es, Gerrit Anne

AU - Virmani, Renu

AU - Popma, Jeffrey

AU - Parides, Michael K.

AU - Kodali, Susheel

AU - Bilello, Michel

AU - Zivadinov, Robert

AU - Akar, Joseph

AU - Furie, Karen L.

AU - Gress, Daryl

AU - Voros, Szilard

AU - Moses, Jeffrey

AU - Greer, David

AU - Forrest, John K.

AU - Holmes, David

AU - Kappetein, Arie P.

AU - Mack, Michael

AU - Baumbach, Andreas

PY - 2017/2/14

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N2 - 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.

AB - 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.

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KW - methodology

KW - neurological definitions

KW - outcomes

KW - stroke

KW - trials

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ER -

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

Abstract

Keywords

ASJC Scopus subject areas

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