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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.

Magnetic Resonance Imaging Outcomes in the Colchicine After Stroke to Prevent Event Recurrence (MR CASPER): A randomized trial to examine the effect of long-term low-dose Colchicine on cerebrovascular disease progression and cognitive decline, incorporating Magnetic Resonance imaging and clinical assessments.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001579785
Acronym
MR-CASPER
Enrollment
200
Registered
2022-12-21
Start date
2023-03-06
Completion date
2024-03-31
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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

South Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026