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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



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)


Validity not established


Normal range for certain patient populations unknown


Timing is critical

Less biased



Subject to laboratory errors