Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke

NCT02184936 | Completed

• 1 other identifier: 24416
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

CT Angiography, CT Perfusion, Ischemic Stroke, Collaterals

Outcome Measures

Primary Outcomes (1)

• Major neurological improvement at 24 hours

  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.

  24 hours post stroke onset

Secondary Outcomes (4)

• 90 day clinical outcome

  90 days

• percent neurologic improvement comparing NIHSS at baseline to 24 hours

  24 hours

• 90-day NIHSS score 0-2

  90 days

• Radiological outcome

  24 hours

Study Arms (1)

acute ischemic stroke

Other: standard of care

Interventions

standard of care OTHER

acute ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke presenting within 12 hours of stroke symptom onset with evidence of intracranial occlusion on routine CTA.

You may qualify if:

• Patient presenting to the emergency department with symptoms consistent with ischemic stroke.
• Age \> 18 yrs.
• Baseline imaging including multi-phase CTA done within 12 hours of stroke symptom onset and initiated before recanalization therapy.
• Evidence of a visible and symptomatic intracranial occlusion on baseline CT-angiography (intracranial ICA, M1 MCA segment +/- intracranial ICA, proximal M2 MCA).
• Treatment with IV tPA and/or IA therapy.

You may not qualify if:

• Intracranial hemorrhage (ICH) identified on baseline CT.
• Previous moderate to large stroke in the ipsilesional hemisphere.
• Modified Rankin Scale \> 2 at baseline.
• Unable to have CT-angio performed due to recent estimated creatinine clearance eCCr\<60 ml/min, contrast allergy or other reasons.
• Participation in another study that results in the patient receiving an investigational drug or therapy.
• Any terminal illness (patient not expected to survive \> 1 year).

Sponsors & Collaborators

• Carol Kenney: lead

Study Sites (2)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Arcispedale Sant'Anna · Department of Neurology

Ferrara, Italy

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bijoy Menon, MD

  University of Calgary, Calgary Stroke Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study co-ordinator

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: September 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); IT (1)