Skip to main content

Table 2 Clinical trial endpoints that may be used to demonstrate cardiac device efficacy in neuroprotection

From: Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit

Endpoint measure Advantages Disadvantages
Incidence of clinical outcomes (such as stroke, transient ischemic attack) Clear indicator of neurologic events Low incidence rate demands large sample size to observe effect
Can be reported in a standardized fashion using the NIH stroke scale and Modified Rankin scale. Cost limitations may prohibit large sample size
May miss silent/subtle clinical events
Neuroimaging (such as diffusion-weighted magnetic resonance imaging, transcranial Doppler ultrasound) Easy and reproducible No standardized definition of endpoint
Widely available Variation in reporting makes cross-study comparisons difficult
May be contraindicated in some patients (for example, those with pacemakers)
Radiographic interpretation may be subjective
Biomarkers (such as S100β, apolipoprotein A1, neuron-specific enolase) Easy Validity not established
Reproducible Normal range for certain patient populations unknown
Objective Timing is critical
Less biased Expensive
   Subject to laboratory errors