Colchicine Atherosclerotic Plaque (CAP) – Biomarker and Imaging Sub-study (of the COLCARDIO-ACS and CASPER Studies)

Colchicine Atherosclerotic Plaque (CAP) – Biomarker and Imaging Sub-study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12622001437752

Acronym

CAP

Enrollment

120

Registered

2022-11-09

Start date

2022-11-21

Completion date

2024-02-29

Last updated

2022-11-14

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

Conditions

None listed

Brief summary

This imaging sub-study will use FDG-PET/CT & CTA angiography (Carotid/ Arotic) to answer the question of if Colchicine administration will reduce vascular inflammation and improve plaque stability. Selected sites participating in the COLCARDIO-ACS (ACTRN12616000400460) and CASPER trials (ACTRN12621001408875) trials will be participating in this CAP sub-study. A sub-set of these sites will collect additional research blood for 40 participants.

Interventions

The following procedures will be performed in a sub-cohort of participants randomised to the COLCARDIO-ACS (ACTRN12616000400460) or CASPER (ACTRN12621001408875) Study: - 18-F-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Imaging at Screening and 12 Months Follow Up. The procedure is anticipated to take up to 2 hours. FDG will be administered intravenously by a nuclear medicine physician, and participants will be asked to sit or lie quietly for 60 mins for the FDG tracer to be absorbed. - Computed Tomography Angiography (CTA) (Cardiac/ Aortic) Imaging at Screening and 12 Months Follow Up. The procedure is anticipated to take up to 20 minutes. Iodine-containing contrast medium (typically less than 100 mls) will be administered intravenously. This procedure will be conducted by either a nuclear medicine physician or a radiologist. - Additional translational research blood collection at Screening, Randomisation, 12 Months Follow Up and End of Treatment.

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

To be eligible participants must be: 1. Eligible for COLCARDIO-ACS (ACTRN12616000400460) or CASPER (ACTRN12621001408875) studies; 2. Aged 50 years or older 3. Willing and able to comply with sub-study visit schedule and nature of required assessments 4. Written informed consent

Exclusion criteria

Participants who do not proceed to run-in for the COLCARDIO-ACS (ACTRN12616000400460) or CASPER (ACTRN12621001408875) studies will not be included.

Outcome results