Atherosclerotic plaque in the carotid arteries is responsible for 10 to 15% of all
ischemic strokes. The ongoing NINDS-funded CREST-2 multicenter randomized clinical trial
is testing whether in the short term (up to 4 years after study entry) procedural
revascularization improves stroke prevention above and beyond what can be achieved with
intensive medical management of vascular risk factors, especially hypertension and
hyperlipidemia. Our proposal is for an observational extension of the CREST-2 clinical
trial to test whether revascularization improves stroke prevention in the clinically
relevant long term (up to 8 to 10 years). The current application proposes to use a
site-less, centralized telephone approach to extend the follow-up of CREST-2 trial
participants for assessing the primary study outcome (stroke) for up to 10 years. The
average follow-up will increase from between 2-3 years (clinic-based randomized trial) to
7-8 years (observational extension). Each patient will be contacted by telephone at
6-month intervals, and queried regarding all hospitalizations since the last contact.
Suspected stroke events will be adjudicated by an expert clinical events committee based
on medical record review.
