Literature DB >> 28171522

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

Alexandra J Lansky1,2,3, Steven R Messé4, Adam M Brickman5, Michael Dwyer6, H Bart van der Worp7, Ronald M Lazar5, Cody G Pietras1,2, Kevin J Abrams8, Eugene McFadden9, Nils H Petersen10, Jeffrey Browndyke11, Bernard Prendergast12, Vivian G Ng1,2, Donald E Cutlip13, Samir Kapadia14, Mitchell W Krucoff15, Axel Linke16, Claudia Scala Moy17, Joachim Schofer18, Gerrit-Anne van Es19, Renu Virmani20, Jeffrey Popma21, Michael K Parides21, Susheel Kodali22, Michel Bilello23, Robert Zivadinov6, Joseph Akar1, Karen L Furie24, Daryl Gress25, Szilard Voros26, Jeffrey Moses22, David Greer10, John K Forrest1, David Holmes27, Arie P Kappetein28, Michael Mack29, Andreas Baumbach3.   

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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Year:  2018        PMID: 28171522      PMCID: PMC6251670          DOI: 10.1093/eurheartj/ehx037

Source DB:  PubMed          Journal:  Eur Heart J        ISSN: 0195-668X            Impact factor:   29.983


  54 in total

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5.  Transient and permanent resolution of ischemic lesions on diffusion-weighted imaging after brief periods of focal ischemia in rats : correlation with histopathology.

Authors:  F Li; K F Liu; M D Silva; T Omae; C H Sotak; J D Fenstermacher; M Fisher; C Y Hsu; W Lin
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6.  Validating the Questionnaire for Verifying Stroke-Free Status (QVSFS) by neurological history and examination.

Authors:  W J Jones; L S Williams; J F Meschia
Journal:  Stroke       Date:  2001-10       Impact factor: 7.914

7.  Reversal of early diffusion-weighted magnetic resonance imaging abnormalities does not necessarily reflect tissue salvage in experimental cerebral ischemia.

Authors:  T M Ringer; T Neumann-Haefelin; R A Sobel; M E Moseley; M A Yenari
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8.  Diffusion-weighted imaging of patients with subacute cerebral ischemia: comparison with conventional and contrast-enhanced MR imaging.

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9.  Complete early reversal of diffusion-weighted imaging hyperintensities after ischemic stroke is mainly limited to small embolic lesions.

Authors:  Fredrik N Albach; Peter Brunecker; Tatiana Usnich; Kersten Villringer; Martin Ebinger; Jochen B Fiebach; Christian H Nolte
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Review 10.  Diffusion-weighted MRI for the "small stuff": the details of acute cerebral ischaemia.

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Journal:  Lancet Neurol       Date:  2004-01       Impact factor: 44.182

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Journal:  Neurocrit Care       Date:  2021-04       Impact factor: 3.210

2.  Long-term impact of β-blocker in elderly patients without myocardial infarction after percutaneous coronary intervention.

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Review 4.  Intimal aortic atherosclerosis in cardiac surgery: surgical strategies to prevent embolic stroke.

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  4 in total

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