Magnetic Resonance Imaging Outcomes in Colchicine After Stroke to Prevent Event Recurrence (CASPER) study cohort: An Imaging sub-study of Colchicine After Stroke to Prevent Event Recurrence.
- Conditions
- Ischemic StrokeAtherosclerosisTransient Ischemic AttackStroke - IschaemicCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemNeurological - Other neurological disorders
- Registration Number
- ACTRN12622001579785
- Lead Sponsor
- South Western Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 200
Eligible participants must meet the following criteria:
1.Be enrolled in CASPER (ACTRN12621001408875) study
2.Be aged 18 years or older
3.Have recovered from an acute ischemic (non-cardioembolic) stroke without major residual disability (mRS less than or equal to 3) as per main CASPER (ACTRN12621001408875) study.
4.Have a serum measurement of high sensitivity C-Reactive Protein (hs-CRP) greater than or equal to 2 mg/L at 4-52 weeks post-event as per main CASPER (ACTRN12621001408875) study.
5.Be willing and able to comply with MR-CASPER sub-study visit schedule and nature of required assessments.
6.Provide written informed consent for the MR CASPER sub-study.
Participants that are not eligible for CASPER (ACTRN12621001408875) study will not be included.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of progressive Inflammatory brain injury after Ischemic stroke compared to placebo, as measured by novel Composite CerebroVascular Disease Burden (CCVDB) outcome, which comprises presence of new ischemic lesions, progression of white matter hyperintensity and brain volume loss as detected by MRI[12 months, 24 months and 36 months post randomization in parent trial CASPER [ACTRN12621001408875]]
- Secondary Outcome Measures
Name Time Method