Neurologic Academic Research Consortium Consensus
What are the neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions?
In accordance with the Academic Research Consortium (ARC) mission statement, the authors convened diverse stakeholders, including physician and scientific leaders in interventional and structural cardiology, electrophysiology, cardiac surgery, neurology, neuroradiology, neuropsychology, clinical trialists representing academic research organizations from the United States and Europe, and representatives from the US Food and Drug Administration and the medical device industry. In-person meetings were held initially. Following the initial meeting, writing groups were established to capture the consensus on specific topics. The resulting draft was presented to and refined by the entire group at the second meeting, and the final document was subsequently adopted by general agreement.
Brain injury related to cardiovascular procedures spans a spectrum from overt stroke to covert injury, and can be classified according to clinical signs and symptoms and neuroimaging. NeuroARC recommends classification on the basis of symptoms and evidence of central nervous system (CNS) injury, including overt (acutely symptomatic) CNS injury (Type 1), covert (acutely asymptomatic) CNS injury (Type 2), and neurological dysfunction (acutely symptomatic) without CNS injury (Type 3).
The authors concluded that systematic application of the proposed definitions and assessments will improve the ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.
This group’s (NeuroARC) recommendations provide a framework for characterization of the clinical consequences of iatrogenic and spontaneous neurological injury following cardiovascular interventions. In general, NeuroARC encourages investigators to incorporate standard definitions and consistent clinical, neuroimaging, and cognitive assessments into their clinical study designs to inform anatomic, physiological, clinical, and functional correlations. Tissue-based identification of CNS infarctions and their clinical correlates are important for informed benefit-risk assessments for cardiovascular procedures, and may help the evaluation of novel approaches to prevent or mitigate brain injury. The ultimate goal is to improve patient outcomes.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Interventions and Imaging
Keywords: Brain Injuries, Cardiac Surgical Procedures, Cardiology Interventions, Central Nervous System, Diagnostic Imaging, Electrophysiology, Infarction, Neuroimaging, Neurology, Neuropsychology, Primary Prevention, Risk Assessment, Stroke, Vascular Diseases
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