CAPTIVA-MRI TRIAL - StrokeNet

CAPTIVA-MRI is an observational multimodal magnetic resonance imaging (MRI) study.

Objective	The primary goal of this study is to determine if MRI biomarkers can potentially identify ICAS patients who fail best medical management. The CAPTIVA-MRI study will inform and facilitate the next generation of ICAS trials and the management of patients with ICAS.
Study Design and Funding Source	CAPTIVA-MRI is an investigator-initiated, multi-center, observational multimodal MR imaging study. NIH / NINDS is the funding source.
Study Population and Treatment Assignments	Subjects with ischemic stroke (defined by a symptomatic cerebral infarct) that is attributed to 70-99% stenosis of a major intracranial artery. The CAPTIVA-MRI study consists of two MRI scans. To be eligible, participants must complete the baseline MRI scan within 51 days of stroke onset. Completion of the baseline scan is required for enrollment. There is a second MRI at one year from enrollment. Because CAPTIVA-MRI is an observational study, there are no treatment assignments. Participants will also receive telephone calls at 4 and 8 months from a member of the study team to check how they are doing, collect current health status information, and assess whether they have had an interval stroke.
Clinical Sites	Approximately 30 sites in the USA.
Primary Endpoints	Primary Outcome: Recurrent ischemic stroke, defined as a symptomatic infarct in the vascular territory of the index stroke artery. This outcome is centrally adjudicated using an American Heart Association definition of ischemic stroke (clinical symptoms consistent with infarct ≥24 hours or clinical symptoms <24 hours with imaging evidence of infarct). Secondary Outcome: Recurrent infarct, a composite of recurrent ischemic stroke and asymptomatic infarct (adjudicated on CAPTIVA-MRI imaging at 12 months) in the vascular territory of the index stroke.
Population	200 patients