@article{5143dee45e364f04a166bac1b2ec35d5,
title = "Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials",
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.",
keywords = "cardiovascular, methodology, neurological definitions, outcomes, stroke, trials",
author = "Lansky, {Alexandra J.} and Mess{\'e}, {Steven R.} and Brickman, {Adam M.} and Michael Dwyer and {Bart Van Der Worp}, H. and Lazar, {Ronald M.} and Pietras, {Cody G.} and Abrams, {Kevin J.} and Eugene McFadden and Petersen, {Nils H.} and Jeffrey Browndyke and Bernard Prendergast and Ng, {Vivian G.} and Cutlip, {Donald E.} and Samir Kapadia and Krucoff, {Mitchell W.} and Axel Linke and {Scala Moy}, Claudia and Joachim Schofer and {Van Es}, {Gerrit Anne} and Renu Virmani and Jeffrey Popma and Parides, {Michael K.} and Susheel Kodali and Michel Bilello and Robert Zivadinov and Joseph Akar and Furie, {Karen L.} and Daryl Gress and Szilard Voros and Jeffrey Moses and David Greer and Forrest, {John K.} and David Holmes and Kappetein, {Arie P.} and Michael Mack and Andreas Baumbach",
note = "Funding Information: Conflict of interest: Dr. Lansky has received research grant support from Keystone Heart, NeuroSave Inc., and Boston Scientific; and has received speaker/consultant fees from Keystone Heart. Dr. Mess{\'e} has received research support from GlaxoSmithKline and Bayer; and is participating on the Clinical Events Committee for the SALUS trial, sponsored by Direct Flow Medical. Dr. Brickman has served as a consultant for Keystone Heart, ERT, and ProPhase LLC. Dr. Dwyer has received research grant support and is on the advisory board for Novartis; has received research grant support and consulting fees from Claret Medical; and is on the advisory board for EMD Serono. Dr. van der Worp is supported by a grant from the Dutch Heart Foundation (2010T075). Dr. Lazar has received grant support and consulting fees from Claret Medical. Dr. Abrams has received consultant fees and equity for Keystone Heart. Dr. Prendergast has received lecture fees from Edwards Lifesciences and Boston Scientific. Dr. Cutlip has received research contract funding from Medtronic and Boston Scientific to his institution. Dr. Kapadia has served as the coprincipal investigator for the Sentinel study sponsored by Claret Medical (unpaid). Dr. Krucoff has received research grants from and served as a consultant for Abbott Vascular, Medtronic, Boston Scientific, and St. Jude Medical. Dr. Linke has received research grant support from Medtronic and Claret Medical; has served as a consultant for Medtronic, Bard, and St. Jude Medical; has received speaker honoraria from Medtronic, St. Jude Medical, Symetis, Edwards Lifesciences, and Boston Scientific; and has stock options in Claret Medical. Dr. Virmani has received research support from 480 Biomedical, Abbott Vascular Japan, Atrium, Biosensors International, Biotronik, Boston Scientific, Cordis Johnson & Johnson, GlaxoSmithKline, Kona, Medtronic, Microport Medical, OrbusNeich Medical, ReCore, SINO Medical Technology, Terumo Corporation, and W.L. Gore. Dr. Popma has received institutional grants from Medtronic, Boston Scientific, Abbott, and Direct Flow Medical; has served on the medical advisory board of Boston Scientific; and has received consultant fees from and has equity in Direct Flow Medical. Dr. Kodali has served on the Steering Committee of the PARTNER III Trial, sponsored by Edwards Lifesciences; has served as a consultant to Medtronic; is the principal investigator of the Sentinel Trial sponsored by Claret Medical; has served on the scientific advisory boards of Thubrikar Aortic Valve Inc. and Dura Biotech; has received research support and travel reimbursement from Edwards Lifesciences, Claret Medical, and Medtronic; and has equity in Thubrikar Aortic Valve (minimal) and Dura Biotech. Dr. Zivadinov has received speaker/consultant fees from Teva Pharmaceuticals, Biogen Idec, EMD Serono, Genzyme-Sanofi, Claret Medical, IMS Health, and Novartis; and has received research grants from Teva Pharmaceuticals, Genzyme-Sanofi, Novartis, Claret Medical, Intekrin, and IMS Health. Dr. Gress has served as a consultant to Medtronic; and has served on the scientific advisory board of Ornim, Keystone Heart, and Silk Road Medical. Dr. Voros is a founder, shareholder, and executive of Global Institute for Research; and is a minority shareholder in Keystone Heart. Dr. Moses has equity in Claret. Dr. Forrest has received grant support and consulting fees from Edwards Lifesciences and Medtronic. Dr. Baumbach has received research grants and speakers fees for Keystone Heart. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: {\textcopyright} The Author 2017.",
year = "2018",
month = may,
day = "14",
doi = "10.1093/eurheartj/ehx037",
language = "English (US)",
volume = "39",
pages = "1687--1697",
journal = "European heart journal",
issn = "0195-668X",
publisher = "Oxford University Press",
number = "19",
}