Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 69, Issue 6, Pages 679-691Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2016.11.045
Keywords
cardiovascular; methodology; neurological definitions; outcomes; stroke trials
Categories
Funding
- Boston Scientific
- Edwards Lifesciences
- Medtronic Corporation
- St. Jude Medical
- NeuroSave Inc.
- Keystone Heart Ltd.
- Keystone Heart
- GlaxoSmithKline
- Bayer
- Direct Flow Medical
- Novartis
- Claret Medical
- Dutch Heart Foundation [2010T075]
- Medtronic
- Abbott Vascular
- 480 Biomedical
- Abbott Vascular Japan
- Atrium
- Biosensors International
- Biotronik
- Cordis Johnson Johnson
- Kona
- Microport Medical
- OrbusNeich Medical
- ReCore
- SINO Medical Technology
- Terumo Corporation
- W.L. Gore
- Abbott
- Teva Pharmaceuticals
- Biogen Idec
- EMD Serono
- Genzyme-Sanofi
- IMS Health
- Intekrin
Ask authors/readers for more resources
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. (C) 2017 The Authors. Published by Elsevier Inc. on behalf of the American College of Cardiology Foundation. All rights reserved.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available