Ischemic Stroke Clinical Trial
Official title:
Precise and Rapid Assessment of Collaterals Using Multi-phase CTA in the Triage of Patients With Acute Ischemic Stroke for IA Therapy
Treatment of acute ischemic stroke (AIS) is aimed at salvaging viable but ischemic brain by
opening the occluded artery and restoring anterograde perfusion as quickly as possible. Time
saved while making critical decisions correctly is vital in AIS management. Conventional
angiography is invasive, resource intensive and not feasible as a fast diagnostic tool.
Perfusion CT and MRI are both susceptible to patient motion, need trained personnel to
process and take at least 10-30 min to acquire and interpret. The investigators have
developed a new imaging tool, multi-phase CT Angiography (CTA), which generates multiple time
resolved images of backfilling arteries beyond a blocked artery filled by collaterals.
Investigators seek to determine: i) if patients with AIS will have a differential clinical
response to early recanalization based on collateral status assessed on multi-phase CTA, ii)
if the extent to which collateral assessment on multi-phase CTA resembles perfusion CT in
predicting which patients will have good clinical outcome with early recanalization, iii)
Identify determinants of variability in native collateral status in patients with acute
ischemic stroke.
Investigators hypothesize that patients with good and intermediate collaterals on multi-phase
CTA achieve good clinical outcome with early recanalization (within 4 hours of baseline
imaging); patients with poor collaterals do not do well even with early recanalization.
Prove-IT is a prospective multi-center hospital-based cohort study of 500 consecutive
patients with acute ischemic stroke presenting within 12 hours of stroke symptom onset with
evidence of intracranial occlusion on routine CTA over 3 years. Calgary and seven other
comprehensive stroke centers will recruit patients into this study. Primary outcome is
defined as a National Institute of Health Stroke Scale (NIHSS) score of 0 to 2 at 24 hours or
an 8-point drop in NIHSS score from baseline to 24 hours. Secondary outcomes are a) 90-day
modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS; b) percent neurologic
improvement comparing NIHSS at baseline to 24 hours; c) 90-day NIHSS score 0-2; d) infarct
volume on 24 hour imaging and e) parenchymal intracerebral hemorrhage type 1 and 2 (ECASS II
criteria) at 24 hrs.
Prove-IT looks to establish the ideal imaging selection tool for intra-arterial (IA) and
thrombolysis decisions in the setting of AIS which is widely available, and can quickly and
reliably detect salvageable brain.
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