Actively Recruiting
Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
Led by University of Edinburgh · Updated on 2026-03-16
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Edinburgh
Lead Sponsor
N
NHS Lothian
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the connections between inflammation, microcalcification, and thrombus activity in the arteries of patients with symptomatic peripheral arterial disease (PAD). PAD causes narrowing and blockages in the arteries of the lower body, leading to reduced blood flow and symptoms ranging from leg pain to loss of limb parts. This study aims to better understand how these processes behave in different parts of the body to help find targeted treatments and reduce risks of heart attacks and strokes. Participants will undergo advanced imaging scans, including whole-body PET-CT and CT angiograms, using tracers that target inflammation, thrombus activity, and microcalcification in atherosclerotic plaques. The study plans to recruit 100 people with symptomatic PAD and may include those also participating in the LEADER-PAD study. Imaging and assessments will be done from the start of the study up to one year later. During the study, participants will have scans to measure PET tracer uptake in symptomatic limbs and other arterial areas to observe plaque activity and changes over time. The team will evaluate plaque characteristics, cardiovascular risk factors, and the progression of microcalcification. The study will monitor participants for up to one year to review these outcomes and better understand disease progression and risks.
CONDITIONS
Brief Title
Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged > 18 years
- Have symptomatic atherosclerotic peripheral artery disease
- Intermittent claudication with ankle/arm blood pressure ratio <0.90 or artery stenosis >50%
- Have at least one of the following: more than one vascular bed affected by atherosclerosis, diabetes, heart failure, or chronic kidney disease (eGFR < 60 mL/min/1.73 m2)
- Presence of rest pain, necrosis, or gangrene of limb
- History of limb bypass surgery or endovascular revascularization procedures
- History of leg or foot amputation for arterial vascular reasons
- Ability to give written or verbal informed consent
You will not qualify if you...
- Contraindication to colchicine or iodinated contrast
- Long term colchicine use for other conditions
- Active diarrhoea
- Recent lower limb revascularisation for symptomatic disease (<6 weeks)
- Renal failure with glomerular filtration rate <30 mL/min/1.73 m2
- Cirrhosis or severe chronic liver disease
- Women who are pregnant or breastfeeding
- Women of child-bearing potential without reliable contraception or planning pregnancy
- Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except azithromycin)
- Unlikely to return for follow-up
- Life expectancy less than 1 year
- Inability or unwillingness to give informed consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline imaging with follow-up imaging at 1 year
Participants undergo a series of whole body PET-CT and CT angiogram scans to assess atherosclerotic plaque activity and characteristics in symptomatic peripheral arterial disease.
1 baseline imaging visit and 1 follow-up imaging visit
Duration - Up to 1 year
Participants are observed for changes in PET tracer uptake and plaque progression over 1 year to understand disease activity and risk.
Imaging assessments from baseline until completion at 1 year
Trial Site Locations
Total: 1 location
1
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SA
Actively Recruiting
Research Team
A
Allison c Winarski, MBChB, MRCS(Ed)
R
Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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