Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02184936 |
Date of registration:
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03/07/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke
PRove-IT |
Scientific title:
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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:
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September 2012 |
Target sample size:
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500 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02184936 |
Study type:
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Observational |
Study design:
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Phase:
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N/A
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Countries of recruitment
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Canada
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Italy
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Contacts
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Name:
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Bijoy Menon, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Calgary, Calgary Stroke Program |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Ischemic Stroke
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Intervention(s)
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Other: standard of care
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Primary Outcome(s)
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Major neurological improvement at 24 hours
[Time Frame: 24 hours post stroke onset]
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Secondary Outcome(s)
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90 day clinical outcome
[Time Frame: 90 days]
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Radiological outcome
[Time Frame: 24 hours]
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percent neurologic improvement comparing NIHSS at baseline to 24 hours
[Time Frame: 24 hours]
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90-day NIHSS score 0-2
[Time Frame: 90 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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