Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.
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.
Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.|Yale Cardiovascular Research Group, New Haven, Connecticut.|Department of Cardiology, St Bartholomew's Hospital, William Harvey Research Institute, and Queen Mary University of London, London, United Kingdom.
Alexandra J
AJ
Lansky
Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
Steven R
SR
Messé
Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, New York.
Adam M
AM
Brickman
Buffalo Neuroimaging Analysis, University of Buffalo, Buffalo, New York.
Michael
M
Dwyer
Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, the Netherlands.
H
H
Bart van der Worp
Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, New York.
Ronald M
RM
Lazar
Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.|Yale Cardiovascular Research Group, New Haven, Connecticut.
Cody G
CG
Pietras
Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami, Miami, Florida.
Kevin J
KJ
Abrams
Department of Cardiology, Cork University Hospital, Cork, Ireland.
Eugene
E
McFadden
Department of Neurology, Yale University School of Medicine, New Haven, Connecticut.
Nils H
NH
Petersen
Division of Geriatric Behavioral Health, Department of Psychiatry & Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.
Jeffrey
J
Browndyke
Department of Cardiology, St. Thomas' Hospital, London, United Kingdom.
Bernard
B
Prendergast
Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.|Yale Cardiovascular Research Group, New Haven, Connecticut.
Vivian G
VG
Ng
Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Donald E
DE
Cutlip
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Samir
S
Kapadia
Department of Cardiology, Duke University Medical Center, Durham, North Carolina.
Mitchell W
MW
Krucoff
Department of Internal Medicine/Cardiology, University of Leipzig, Leipzig, Germany.
Axel
A
Linke
Office of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.
Claudia
C
Scala Moy
Medicare Center and Department for Percutaneous Interventions of Structural Heart Disease, Albertine Heart Center, Hamburg, Germany.
Joachim
J
Schofer
Cardialysis, Rotterdam, the Netherlands.
Gerrit-Anne
GA
van Es
CVpath Institute, Gaithersburg, Maryland.
Renu
R
Virmani
Icahn School of Medicine at Mount Sinai Group, New York, New York.
Jeffrey
J
Popma
Icahn School of Medicine at Mount Sinai Group, New York, New York.
Michael K
MK
Parides
Division of Cardiology, Department of Internal Medicine, Columbia University Medical Center, New York, New York.
Susheel
S
Kodali
Department of Radiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
Michel
M
Bilello
Buffalo Neuroimaging Analysis, University of Buffalo, Buffalo, New York.
Robert
R
Zivadinov
Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
Joseph
J
Akar
Department of Neurology, Rhode Island Hospital, Providence, Rhode Island.
Karen L
KL
Furie
Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, Nebraska.
Daryl
D
Gress
Global Institute for Research and Global Genomics Group, Richmond, Virginia.
Szilard
S
Voros
Division of Cardiology, Department of Internal Medicine, Columbia University Medical Center, New York, New York.
Jeffrey
J
Moses
Department of Neurology, Yale University School of Medicine, New Haven, Connecticut.
David
D
Greer
Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
John K
JK
Forrest
Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.
David
D
Holmes
Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands; and the.
Arie P
AP
Kappetein
Department of Cardiovascular Surgery, The Heart Hospital Baylor Plano Research Center, Plano Texas. Grants to support travel costs, meeting rooms, and lodging for academic attendees at the San Francisco and New York meetings were provided by Boston Scientific, Edwards Lifesciences, Medtronic Corporation, St. Jude Medical, NeuroSave Inc., and Keystone Heart Ltd.
Michael
M
Mack
Department of Cardiology, St Bartholomew's Hospital, William Harvey Research Institute, and Queen Mary University of London, London, United Kingdom.
Andreas
A
Baumbach
D013504:Cardiovascular Surgical Procedures / Q000009:adverse effects*; D002404:Catheterization / Q000009:adverse effects; D002986:Clinical Trials as Topic; D023381:Endpoint Determination; D006801:Humans; D009422:Nervous System Diseases / Q000145:classification / Q000175:diagnosis* / Q000209:etiology*; D009460:Neurologic Examination; D011183:Postoperative Complications; D018570:Risk Assessment