Proposed standardized neurological endpoints for cardiovascular clinical trials

被引：50

作者：

Lansky, Alexandra J. ^{[1
,2
,3
,4
]}

Messe, Steven R. ^{[5
]}

Brickman, Adam M. ^{[6
]}

Dwyer, Michael ^{[7
]}

van der worp, H. Bart ^{[8
]}

Lazar, Ronald M. ^{[6
]}

Pietras, Cody G. ^{[1
,2
]}

Abrams, Kevin J. ^{[9
]}

McFadden, Eugene ^{[10
]}

Petersen, Nils H. ^{[11
]}

Browndyke, Jeffrey ^{[12
]}

Prendergast, Bernard ^{[13
]}

Ng, Vivian G. ^{[1
,2
]}

Cutlip, Donald E. ^{[14
]}

Kapadia, Samir ^{[15
]}

Krucoff, Mitchell W. ^{[16
]}

Linke, Axel ^{[17
]}

Moy, Claudia Scala ^{[18
]}

Schofer, Joachim ^{[19
,20
]}

van Es, Gerrit-Anne ^{[21
]}

Virmani, Renu ^{[22
]}

Popma, Jeffrey ^{[23
]}

Parides, Michael K. ^{[23
]}

Kodali, Susheel ^{[24
]}

Bilello, Michel ^{[25
]}

Zivadinov, Robert ^{[7
]}

Akar, Joseph ^{[1
]}

Furie, Karen L. ^{[26
]}

Gress, Daryl ^{[27
]}

Voros, Szilard ^{[28
,29
]}

Moses, Jeffrey ^{[24
]}

Greer, David ^{[11
]}

Forrest, John K. ^{[1
]}

Holmes, David ^{[30
]}

Kappetein, Arie P. ^{[31
]}

Mack, Michael ^{[32
]}

Baumbach, Andreas ^{[3
,4
]}

机构：

[1] Yale Sch Med, Dept Internal Med, Div Cardiovasc Med, 135 Coll St,Suite 101, New Haven, CT 06510 USA

[2] Yale Cardiovasc Res Grp, New Haven, CT USA

[3] St Bartholomews Hosp, William Harvey Res Inst, Dept Cardiol, London, England

[4] Queen Mary Univ London, London, England

[5] Hosp Univ Penn, Dept Neurol, 3400 Spruce St, Philadelphia, PA 19104 USA

[6] Columbia Univ, Coll Phys & Surg, Dept Neurol, New York, NY USA

[7] SUNY Buffalo, Buffalo Neuroimaging Anal, Buffalo, NY USA

[8] Univ Med Ctr Utrecht, Brain Ctr Rudolf Magnus, Dept Neurol & Neurosurg, Utrecht, Netherlands

[9] Baptist Hosp Miami, Baptist Cardiac & Vasc Inst, Miami, FL USA

[10] Cork Univ Hosp, Dept Cardiol, Cork, Ireland

[11] Yale Univ, Sch Med, Dept Neurol, New Haven, CT 06510 USA

[12] Duke Univ, Med Ctr, Dept Psychiat & Behav Sci, Div Geriatr Behav Hlth, Durham, NC USA

[13] St Thomas Hosp, Dept Cardiol, London, England

[14] Beth Israel Deaconess Med Ctr, Dept Med, Div Cardiovasc Med, Boston, MA 02215 USA

[15] Cleveland Clin, Dept Cardiovasc Med, Cleveland, OH 44106 USA

[16] Duke Univ, Med Ctr, Dept Cardiol, Durham, NC USA

[17] Univ Leipzig, Dept Internal Med Cardiol, Leipzig, Germany

[18] NINDS, Off Clin Res, Bldg 36,Rm 4D04, Bethesda, MD 20892 USA

[19] Albertine Heart Ctr, Medicare Ctr, Hamburg, Germany

[20] Albertine Heart Ctr, Dept Percutaneous Intervent Struct Heart Dis, Hamburg, Germany

[21] Cardialysis, Rotterdam, Netherlands

[22] CVpath Inst, Gaithersburg, MD USA

[23] Icahn Sch Med Mt Sinai Grp, New York, NY USA

[24] Columbia Univ, Med Ctr, Dept Internal Med, Div Cardiol, New York, NY USA

[25] Hosp Univ Penn, Dept Radiol, 3400 Spruce St, Philadelphia, PA 19104 USA

[26] Rhode Isl Hosp, Dept Neurol, Providence, RI USA

[27] Univ Nebraska Med Ctr, Dept Neurol Sci, Omaha, NE USA

[28] Global Inst Res, Richmond, VA USA

[29] Global Genom Grp, Richmond, VA USA

[30] Mayo Clin, Dept Cardiovasc Dis, Rochester, MN USA

[31] Erasmus Univ, Med Ctr, Dept Cardiothorac Surg, Rotterdam, Netherlands

[32] Baylor Plano Res Ctr, Heart Hosp, Dept Cardiothorac Surg, Plano, TX USA

来源：

EUROPEAN HEART JOURNAL | 2018年 / 39卷 / 19期

关键词：

cardiovascular; methodology; neurological definitions; outcomes; stroke; trials; AORTIC-VALVE IMPLANTATION; ASSOCIATION/AMERICAN STROKE ASSOCIATION; ACADEMIC RESEARCH CONSORTIUM; TRANSIENT ISCHEMIC ATTACK; HEALTH-CARE PROFESSIONALS; CEREBRAL-ISCHEMIA; COGNITIVE IMPAIRMENT; CONSENSUS DOCUMENT; CARDIAC-SURGERY; DIFFUSION;

D O I：

10.1093/eurheartj/ehx037

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1687 / 1697

页数：11

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