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

Alexandra J Lansky, Steven R Messé, Adam M Brickman, Michael Dwyer, H Bart van der Worp, Ronald M Lazar, Cody G Pietras, Kevin J Abrams, Eugene McFadden, Nils H Petersen, Jeffrey Browndyke, Bernard Prendergast, Vivian G Ng, Donald E Cutlip, Samir Kapadia, Mitchell W Krucoff, Axel Linke, Claudia Scala Moy, Joachim Schofer, Gerrit-Anne van Es, Renu Virmani, Jeffrey Popma, Michael K Parides, Susheel Kodali, Michel Bilello, Robert Zivadinov, Joseph Akar, Karen L Furie, Daryl Gress, Szilard Voros, Jeffrey Moses, David Greer, John K Forrest, David Holmes, Arie P Kappetein, Michael Mack, Andreas Baumbach, Alexandra J Lansky, Steven R Messé, Adam M Brickman, Michael Dwyer, H Bart van der Worp, Ronald M Lazar, Cody G Pietras, Kevin J Abrams, Eugene McFadden, Nils H Petersen, Jeffrey Browndyke, Bernard Prendergast, Vivian G Ng, Donald E Cutlip, Samir Kapadia, Mitchell W Krucoff, Axel Linke, Claudia Scala Moy, Joachim Schofer, Gerrit-Anne van Es, Renu Virmani, Jeffrey Popma, Michael K Parides, Susheel Kodali, Michel Bilello, Robert Zivadinov, Joseph Akar, Karen L Furie, Daryl Gress, Szilard Voros, Jeffrey Moses, David Greer, John K Forrest, David Holmes, Arie P Kappetein, Michael Mack, Andreas Baumbach

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.

Figures

Figure 1
Figure 1
Imaging-Driven Diagnosis of Stroke and CNS Infarction (for Studies With Routine Neuroimaging). Assessment of the consistency of signs and symptoms with lesion distribution is a matter of clinical judgment and, in clinical trials, should be adjudicated by an independent Clinical Events Committee. CNS, central nervous system; DW, diffusion-weighted; MRI, magnetic resonance imaging; TIA, transient ischemic attack.
Figure 2
Figure 2
Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: Recommended Timing of Clinical and Imaging Evaluations. This figure provides recommended and optional assessments for each time point; appropriate follow-up duration will vary with device/procedure type and the goals of the study. *Cognitive screening (e.g., Montreal Cognitive Assessment) is recommended for all trial categories. Comprehensive cognitive assessment is recommended for studies with neurological outcomes as efficacy endpoints (Categories II and III in Table 2), and optional for safety studies (Category I in Table 2). MRI = magnetic resonance imaging.

Source: PubMed

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