None listed
Conditions
Brief summary
The sub-study MR-CASPER will incorporate MR Imaging and clinical assessments to examine the effect of long-term low-dose colchicine on cerebrovascular disease progression and cognitive decline using a Composite CerebroVascular Disease Burden (CCVDB) outcome measure. The aim of this study is to examine low-dose colchicine’s potential effect on the inflammatory vascular injury responsible for both recurrent stroke and post-stroke cognitive decline. Selected sites in the CASPER (ACTRN12621001408875) trial will participate in this MR-CASPER sub study, with an aim to recruit up to 200 participants who will undergo MRI for the MR-CASPER study, while concurrently participating in the CASPER trials (ACTRN12621001408875) study.
Interventions
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.
Sponsors
Study design
Eligibility
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.
Exclusion criteria
Participants that are not eligible for CASPER (ACTRN12621001408875) study will not be included.