Imaging plaque activity across the body in people with symptomatic peripheral arterial disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will recruit 100 adults with symptomatic peripheral arterial disease to undergo whole-body PET-CT scans with three tracers ([68Ga]DOTATATE, [18F]GP1, [18F]NaF) and a CT angiogram. Investigators will quantify inflammation, thrombus activity and microcalcification in plaques across peripheral and systemic vascular territories and compare patterns between lesion sites. Participants may be co-enrolled in the LEADER-PAD study to allow integration with other clinical and biological data. The goal is to map how different plaque processes relate to each other and to clinical features without changing participants' usual care.

Why it matters

Who can join: the full rules

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 it's running

• Royal Infirmary of Edinburgh
  Edinburgh, Midlothian, United Kingdom Recruiting

Study contacts

• Principal investigator: Rachael O Forsythe, MBChB, PhD, FRCS (Vascular) — University of Edinburgh
• Study coordinator: Allison c Winarski, MBChB, MRCS(Ed)
• Email: awinarsk@ed.ac.uk
• Phone: +447495905258

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.