Pulse Brain · Growing Health Evidence Index
Tier 4 — Narrative / commentaryPeer-reviewed

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials

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

Journal of the American College of Cardiology · 2017

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Summary

This consensus paper, published in the Journal of the American College of Cardiology in 2017, proposes standardised neurological endpoints for cardiovascular clinical trials. Authored by a large international group of cardiologists, neurologists, and neuroradiologists, the work addresses the heterogeneity in how neurological complications—particularly stroke and cognitive impairment—have been assessed across cardiology studies. The authors recommend harmonised measurement protocols to improve comparability and statistical power in detecting brain-related adverse events associated with cardiovascular procedures and interventions.

Regional applicability

The proposed standardised endpoints would support UK-based cardiovascular research and clinical trials, facilitating alignment with international trial protocols and enabling more robust comparative effectiveness analyses. These recommendations are particularly relevant for NHS-funded cardiovascular research networks and cardiac intervention centres monitoring patient safety outcomes.

Key measures

Neurological assessment protocols; cognitive testing batteries; stroke severity scales; endpoints for neurocognitive injury in cardiovascular interventions

Outcomes reported

The paper proposes standardised neurological endpoints for use in cardiovascular clinical trials, addressing the need for consistent assessment of neurological complications and cognitive outcomes. It reviews existing neurological assessment tools and recommends harmonised protocols for detecting stroke, cognitive decline, and other brain-related adverse events in cardiology populations.

Theme
Measurement & metrics
Subject
Measurement methods & nutrient profiling
Study type
Guideline
Study design
Narrative review and guideline development
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/j.jacc.2016.11.045
Catalogue ID
SNmohbau85-0450s2

Topic tags

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