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Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke (PRove-IT)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2016 by Carol Kenney, University of Calgary
Sponsor:
Information provided by (Responsible Party):
Carol Kenney, University of Calgary
ClinicalTrials.gov Identifier:
NCT02184936
First received: July 3, 2014
Last updated: May 10, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention
Ischemic Stroke Other: standard of care

Study Type: Observational
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

Further study details as provided by Carol Kenney, University of Calgary:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 90 day clinical outcome [ Time Frame: 90 days ]
    1. 90-day modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS
    2. 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


Estimated Enrollment: 500
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)
Groups/Cohorts Assigned Interventions
acute ischemic stroke Other: standard of care

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Intracranial hemorrhage (ICH) identified on baseline CT.
  2. Previous moderate to large stroke in the ipsilesional hemisphere.
  3. Modified Rankin Scale > 2 at baseline.
  4. Unable to have CT-angio performed due to recent estimated creatinine clearance eCCr<60 ml/min, contrast allergy or other reasons.
  5. Participation in another study that results in the patient receiving an investigational drug or therapy.
  6. Any terminal illness (patient not expected to survive > 1 year).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02184936

Contacts
Contact: Bijoy Menon, MD 403-944-8107 Bijoy.menon@albertahealthservices.ca
Contact: Mayank Goyal, MD 403-944-3379 mgoyal@ucalgary.ca

Locations
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Principal Investigator: Bijoy Menon, MD         
Italy
Arcispedale Sant'Anna · Department of Neurology Not yet recruiting
Ferrara, Italy
Principal Investigator: Enrico Fainardi, MD         
Sponsors and Collaborators
Carol Kenney
Investigators
Principal Investigator: Bijoy Menon, MD University of Calgary, Calgary Stroke Program
  More Information

Additional Information:
Responsible Party: Carol Kenney, Study co-ordinator, University of Calgary
ClinicalTrials.gov Identifier: NCT02184936     History of Changes
Other Study ID Numbers: 24416
Study First Received: July 3, 2014
Last Updated: May 10, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant date will be shared, overall data( anonymous) will be available and shared

Keywords provided by Carol Kenney, University of Calgary:
CT Angiography, CT Perfusion, Ischemic Stroke, Collaterals

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 22, 2017