At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Whole body [68Ga]DOTATATE PET-CT (radiation), Whole body [18F]GP1 PET-CT (radiation), Whole body [18F]NaF PET-CT (radiation), Whole body CT angiogram (radiation)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Whole body [68Ga]DOTATATE PET-CT — radiation: Targeting vascular inflammation · Whole body [18F]GP1 PET-CT — radiation: Targeting thrombus activity · Whole body [18F]NaF PET-CT — radiation: Targeting vascular microcalcification · Whole body CT angiogram — radiation: To determine anatomical and morphological atherosclerotic plaque characteristics
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2025-07-31
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for peripheral arterial disease
- • Clinical study - 100 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with peripheral arterial disease
Where?
- • Edinburgh - Royal Infirmary of Edinburgh
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
In peripheral arterial disease (PAD), arteries in the lower body can become narrowed and develop blockages due to a process called atherosclerosis, leading to reduced blood flow to the lower limbs. Symptoms can range from mild cramping pain in legs on walking, to loss of parts of the leg. Patients with PAD are also at a high risk of blockages in other arteries in the body that can lead to problems such as heart attacks and strokes. Despite improvements in medical treatments and surgery, the outlook for patients with PAD has not improved. Further information is required to understand the relationships between the processes that lead to narrowing and blockages (atherosclerosis) of the arteries and if they behave the same in different parts of the body. This can help to identify targeted treatments to reduce the risk of the disease getting worse and avoid heart attacks and strokes. In this study investigators plan to recruit 100 people with symptomatic PAD to undergo a series of whole body PET-CT and CT angiogram scans using different tracers targeting the processes involved in atherosclerosis. Investigators will aim to co-enrol patients taking part in the LEADER-PAD study (NCT04774159).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Male or female aged \> 18 years
- ✓causing symptoms atherosclerotic peripheral artery disease;
- ✓Intermittent claudication; with ankle/arm blood pressure ratio \<0.90 or artery stenosis \>50% in addition to at...
- ✓\>1 vascular bed affected by atherosclerosis
- ✓Diabetes
Who cannot take part
- ✗safety concern to colchicine or iodinated contrast
- ✗Long term requirement for colchicine for another clinical indication
- ✗Active diarrhoea
- ✗Recent lower limb revascularisation for causing symptoms disease (\<6 weeks)
- ✗kidney failure (glomerular filtration rate \<30 mL/min/1.73 m2)
See the full criteria
Where Is This Study? (1 UK site)
Royal Infirmary of Edinburgh
Edinburgh EH16 4SA, United Kingdom
How to Get in Touch
Allison c Winarski, MBChB, MRCS(Ed)
Sponsor contactCONTACT
Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
Sponsor contactCONTACT
