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.

Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: The cohort of participants randomized into the intervention arm of CASPER [ACTRN12621001408875] i.e., taking oral Colchicine 0.5mg tablet daily for median 3 years will make up the intervention arm of participants in the MR‐CASPER sub‐study, and will upon completing registration, run‐in and randomization phases of CASPER [ACTRN12621001408875] undergo: ‐ Baseline Magnetic Resonance Imaging (MRI), with no contrast dye injected and a projected 30 min total scan time will be conducted by radiologist. ‐Baseline cognitive assessment; Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT) and Brief Memory and Executive Test (BMET) performed by study investigators. ‐Baseline mood assessment; Depression, Anxiety and Stress Scale 42 (DASS 42) performed by study investigators. ‐Baseline Quality of life assessment; 36‐item short form survey (SF‐36) performed by study investigators. ‐ Follow‐up MRI annually with no contrast dye injected and a projected 30 min total scan time, in line with the 12month, 24 month and 36month follow‐up visits employed in the parent study CASPER [ACTRN12621001408875] conducted by radiologist. ‐ Follow‐up cognitive (MOCA, TMT, BMET), mood (DASS 42) and quality of life (SF‐36) clinical assessments are projected to take up to 45min, in line with the 12month, 24 month and 36month follow‐up visits employed in the parent study CASPER [ACTRN12621001408875] conducted by study investigators. Participant adherence to the MRI intervention will be monitored by scheduled visits attendance checklists. Trial synergies include using concurrent assessment time‐points for both studies, with assessors also shared to further reduce participant burden. CONDITION: Cardiovascular ‐ Diseases of the vasculature and circulation including the lymphatic system Ischemic Stroke;Atherosclerosis;Transient Ischemic Attack; ; Ischemic Stroke ; Atherosclerosis ; Transient Ischemic Attack Neurological ‐ Other neurological disorders Stroke ‐ Ischaemic PRIMARY OUTCOME: 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]] INCLUSION CRITERIA: 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. SECONDARY OUTCOME: Effect of colchicine on cognitive decline after ischemic stroke compared to placebo as measured by BMET clinical cognitive assessments performed by study investigators. [12 months, 24 months and 36 months post randomization in parent trial CASPER [ACTRN12621001408875]] Effect of colchicine on cognitive decline after ischemic stroke compared to placebo as measured by MOCA clinical cognitive assessments performed by study investigators. [12 months, 24 months and 36 months post randomization in parent trial CASPER [ACTRN12621001408875]] Effect of colchicine on cognitive decline after ischemic stroke compared to placebo as measured by TMT clinical cognitive assessments performed by study investigators. [12 months, 24 months and 36 months post randomization in parent trial CASPER [ACTRN12621001408875]] Effect of Colchicine on quality‐of‐life measures after ischemic stroke compared to placebo as measured by the DASS 42 mood clinical assessment as conducted by study investigators. [12 months, 24 months and 36 months post randomization in parent trial CASPER [ACTRN12621001408875]] Effect of Colchicine on quality‐of‐life measures after ischemic stroke compared to placebo as measured by the SF 36 quality‐of‐life clinical assessment conducted by study investigators.[12 months, 24 months and 36 months post randomization in parent trial CASPER [ACTRN12621001408875]] Identification of new ischemic lesions (cortical or subcortical infarcts) as detected by MRI[12 months, 24 months and 36 months post randomization in parent trial CASPER [ACTRN12621001408875]] Measure of brain volume loss as detected by MRI[12 months, 24 months and 36 months post randomization in parent trial CASPER [ACTRN12621001408875] ; ] Progression of white mater hyperintensity as detected by MRI[12 months, 24 months and 36 months post randomization in parent trial CASPER [ACTRN12621001408875]] Rate of stenosis, signal change indicating atherosclerotic disease as detected by MRI[12 months, 24 months and 36 months post randomization in parent trial CASPER [ACTRN12621001408875]]
Epistemonikos ID: 597400c9b6b409e120e1e0600c467312f4d5579f
First added on: Aug 26, 2024