RecruitingNCT07472049

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Sponsor

University of Edinburgh

Enrollment

100 participants

Start Date

Jul 31, 2025

Study Type

OBSERVATIONAL

Conditions

Peripheral Arterial Disease Chronic Limb Threatening Ischemia

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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

Exclusion Criteria12

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