The Neurologic Academic Research Consortium proposes standardized definitions and assessments for neurological endpoints to improve the evaluation of safety and effectiveness in cardiovascular trials.
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.
“The current stroke definitions used in cardiovascular trials focus on the most extreme, devastating strokes, which are only one component of a spectrum of brain injury that is relevant to patients with cardiovascular disease.”
Lansky et al. (2017) conducted a review in Neurological complications in cardiovascular trials. The Neurologic Academic Research Consortium proposes standardized definitions and assessments for neurological endpoints to improve the evaluation of safety and effectiveness in cardiovascular trials.