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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02184936
Date of registration: 03/07/2014
Prospective Registration: No
Primary sponsor: Carol Kenney
Public title: Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke PRove-IT
Scientific title: Precise and Rapid Assessment of Collaterals Using Multi-phase CTA in the Triage of Patients With Acute Ischemic Stroke for IA Therapy
Date of first enrolment: September 2012
Target sample size: 500
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02184936
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Canada Italy
Contacts
Name:     Bijoy Menon, MD
Address: 
Telephone:
Email:
Affiliation:  University of Calgary, Calgary Stroke Program
Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Ischemic Stroke
Intervention(s)
Other: standard of care
Primary Outcome(s)
Major neurological improvement at 24 hours [Time Frame: 24 hours post stroke onset]
Secondary Outcome(s)
90 day clinical outcome [Time Frame: 90 days]
Radiological outcome [Time Frame: 24 hours]
percent neurologic improvement comparing NIHSS at baseline to 24 hours [Time Frame: 24 hours]
90-day NIHSS score 0-2 [Time Frame: 90 days]
Secondary ID(s)
24416
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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