Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsN/A

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

Sponsor: University of Edinburgh

NCT ID: NCT07472049

View on ClinicalTrials.gov ↗

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).

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

eGFR

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
Inclusion Criteria: * 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 Criteria: * 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 Is This Study? (1 UK site)

Royal Infirmary of Edinburgh

Edinburgh EH16 4SA, United Kingdom

Recruiting
Site contact (verified)
Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)Principal Investigator
Allison C Winarski, MBChB MRSC(Ed)+447495905258awinarsk@ed.ac.uk
Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)01312423585rachael.forsythe@ed.ac.uk

How to Get in Touch

Allison c Winarski, MBChB, MRCS(Ed)

Sponsor contact

CONTACT

+447495905258 awinarsk@ed.ac.uk

Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)

Sponsor contact

CONTACT

+44 01312423585 rachael.forsythe@ed.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-09