Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke (PRove-IT)
Treatment of acute ischemic stroke 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 acute ischemic stroke 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 selection tool, multi-phase CT Angiography (CTA), which generates multiple time resolved images of backfilling arteries beyond a blocked artery filled by collaterals.
The investigators seek to determine: i) if patients with acute ischemic stroke 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.
The 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 acute ischemic stroke which is widely available, and can quickly and reliably detect salvageable brain.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Precise and Rapid Assessment of Collaterals Using Multi-phase CTA in the Triage of Patients With Acute Ischemic Stroke for IA Therapy|
- Major neurological improvement at 24 hours [ Time Frame: 24 hours post stroke onset ]defined as a NIHSS score of 0 to 2 at 24 hours or an 8-point drop in NIHSS score from baseline to 24 hours.
- 90 day clinical outcome [ Time Frame: 90 days ]
- 90-day modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS
- Ordinal (shift) analysis across the mRS scale
- percent neurologic improvement comparing NIHSS at baseline to 24 hours [ Time Frame: 24 hours ]
- 90-day NIHSS score 0-2 [ Time Frame: 90 days ]
- Radiological outcome [ Time Frame: 24 hours ]infarct volume on 24 hour imaging and parenchymal intracerebral hemorrhage type 1 and 2 (ECASS II criteria) at 24 hrs
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02184936
|Contact: Bijoy Menon, MD||403-944-8107||Bijoy.email@example.com|
|Contact: Mayank Goyal, MDfirstname.lastname@example.org|
|Foothills Medical Centre||Recruiting|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator: Bijoy Menon, MD|
|Arcispedale Sant'Anna · Department of Neurology||Not yet recruiting|
|Principal Investigator: Enrico Fainardi, MD|
|Principal Investigator:||Bijoy Menon, MD||University of Calgary, Calgary Stroke Program|