Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
Recruiting now
Conditions studied: Peripheral Arterial Disease, Chronic Limb Threatening Ischemia
In brief
The goal of this observational study is to characterise the relationships between inflammation, microcalcification and thrombus activity in atherosclerotic plaques in peripheral and systemic vascular territories in patients with symptomatic peripheral arterial disease.
Key facts
- Study ID
- NCT07472049
- Run by
- University of Edinburgh
- People needed
- 100
- Starts
- 2025-07-31
- Expected to finish
- 2029-07-01
- Last updated by the study team
- 2026-03-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female aged > 18 years
- Symptomatic atherosclerotic peripheral artery disease;
- Intermittent claudication; with ankle/arm blood pressure ratio <0.90 or artery stenosis >50% in addition to at least one of the following;
- >1 vascular bed affected by atherosclerosis
- Diabetes
- Heart failure
- Chronic kidney disease (eGFR < 60 mL/min/1.73 m2)
- Rest pain or necrosis of limb or gangrene of limb
- Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery
- Leg or foot amputation for arterial vascular indications
- Ability to give written or verbal informed consent
You may not qualify if…
- Contraindication to colchicine or iodinated contrast
- Long term requirement for colchicine for another clinical indication
- Active diarrhoea
- Recent lower limb revascularisation for symptomatic disease (<6 weeks)
- Renal failure (glomerular filtration rate <30 mL/min/1.73 m2)
- Cirrhosis or severe chronic liver disease
- Women who are pregnant or breast-feeding
- Women of child-bearing potential not protected by reliable contraception or is planning conception during the study
- Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (apart from azithromycin)
- Patients deemed unlikely to return for follow up
- Life expectancy <1 year
- Inability or unwilling to give informed consent
Where it is running
- Royal Infirmary of Edinburgh — Edinburgh, Midlothian, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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