Stroke Risk Assessment and Future Stroke Primary Prevention Trial: Workshop Summary

January 13 - 14, 2004

As the U.S. population ages, stroke deaths are projected to double during the next thirty years. However, the increase in stroke-related mortality does not fully reflect the public health burden of stroke, as most strokes are not fatal and often result in chronic neurological disability, including vascular dementia. In addition, brain imaging studies indicate that risk factors for clinical (overt) strokes, such as hypertension, often lead to covert infarcts, resulting in subtle brain injury and cognitive decline. Although data on the incidence of covert brain infarcts are still sketchy, available statistics on clinical strokes indicate that of the 700,000 cases recorded each year, 500,000 (or about 70%) are first-ever strokes. It is clear that, to reduce the neurological burden of clinical stroke, efforts must focus on primary prevention.

In April 2002, the NINDS-sponsored Stroke Progress Review Group (Stroke PRG) met to identify and prioritize research needs in basic science, epidemiology, and clinical studies related to stroke. Among the priorities identified by the Stroke PRG was a need for greater focus on primary prevention of stroke [include link to the report from this meeting]. To address this need, the National Institute of Neurological Disorders and Stroke held a workshop titled "Stroke Risk Assessment and Future Stroke Primary Prevention Trials" on January 12-13, 2004.

The Workshop discussions focused on issues in stroke risk assessment and the need for continued refinement of existing tools for identification of high-risk patients; the high-risk vs. population based approaches to primary prevention; characteristics of ideal candidate treatments in primary stroke prevention trials; potential candidate drugs, such as the “polypill”, aspirin, and insulin sensitizers; the use of surrogate markers and measures of subclinical disease as either risk assessment tools or as outcomes; and methodological and logistical issues in stroke primary prevention trials. Special emphasis was placed on the importance of assessing cognitive decline as an important consequence of covert and clinical vascular injury of the brain.

The workshop resulted in specific recommendations for the next research steps leading toward stroke primary prevention clinical trials. The participants concluded that although scientific or logistic barriers to stroke primary prevention trials are challenging, they are not insurmountable.