Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke (PRove-IT)
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|ClinicalTrials.gov Identifier: NCT02184936|
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : October 30, 2017
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.
|Condition or disease||Intervention/treatment|
|Ischemic Stroke||Other: standard of care|
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||Precise and Rapid Assessment of Collaterals Using Multi-phase CTA in the Triage of Patients With Acute Ischemic Stroke for IA Therapy|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
|acute ischemic stroke||
Other: standard of care
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184936
|Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 2T9|
|Arcispedale Sant'Anna · Department of Neurology|
|Principal Investigator:||Bijoy Menon, MD||University of Calgary, Calgary Stroke Program|