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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02184936
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Carol Kenney, University of Calgary

Tracking Information
First Submitted Date July 3, 2014
First Posted Date July 9, 2014
Last Update Posted Date October 30, 2017
Study Start Date September 2012
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 8, 2014)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke
Official Title Precise and Rapid Assessment of Collaterals Using Multi-phase CTA in the Triage of Patients With Acute Ischemic Stroke for IA Therapy
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Ischemic Stroke
Intervention Other: standard of care
Study Groups/Cohorts acute ischemic stroke
Intervention: Other: standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2014)
500
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02184936
Other Study ID Numbers 24416
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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
Responsible Party Carol Kenney, University of Calgary
Study Sponsor Carol Kenney
Collaborators Not Provided
Investigators
Principal Investigator: Bijoy Menon, MD University of Calgary, Calgary Stroke Program
PRS Account University of Calgary
Verification Date October 2017