SISYPHUS

• Research type

  Research Study

• Full title

  SymptomatIc and Systemic atherosclerotic plaque activity in patients with peripheral arterial diease using novel imaging.

• IRAS ID

  350472

• Contact name

  Rachael Forsythe

• Contact email

  rachael.forsythe@ed.ac.uk

• Sponsor organisation

  University of Edinburgh

• Duration of Study in the UK

  1 years, 11 months, 30 days

• Research summary

  Peripheral artery disease (PAD) is the result of atherosclerotic narrowing and blockages in the arteries of the lower limbs and affects 20% of people over 60. For end stage PAD or chronic limb threatening ischaemia (CLTI), the mortality rate remains stubbornly high and is worse than many common cancers. Cardiovascular disease is the main cause of death in these patients who often have concurrent atherosclerosis in other arterial beds such as the heart and the brain.

  Atherosclerosis is the result of a complex process involving inflammation, calcification (hardening) and thrombus(clot) formation in the arteries. Novel imaging techniques have allowed us to observe these processes, though previous studies have mainly focused on a single process in a single arterial bed. However, atherosclerosis can occur across multiple beds simultaneously.

  To better understand the relationship between inflammation, calcification and thrombus activity we will use innovative imaging techniques including total body positron emission tomography (PET) and computed tomography (CT) angiography with radiotracers (dye injected into the vein to create the scan images). This will be the first total body evaluation of atherosclerosis in patients with PAD comparing disease in the lower limbs to those other arterial beds.

  By opportunistically recruiting patients who are enrolled in the low-dose colchicine in patients with PAD to address residual vascular risk (LEADER PAD) trial we have the unique opportunity to provide insight into the effects of colchicine, an anti-inflammatory drug, on the processes involved in atherosclerosis as well as the effect on different arterial beds.

  We plan to recruit 100 patients for the study, lasting 12 months and plan to conduct the following assessments;
  1. PET CT and CT angiography scans at baseline, 16 weeks and 12 months
  2. Clinical assessment and review of symptoms at baseline, 16 weeks and 12 months
  3. Blood samples at baseline, 16 weeks and 12 months
  

• REC name

  North of Scotland Research Ethics Committee 2

• REC reference

  25/NS/0036

• Date of REC Opinion

  13 May 2025

• REC opinion

  Further Information Favourable Opinion