Imaging plaque activity across the body in people with symptomatic peripheral arterial disease
Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
This project will use whole-body PET-CT and CT angiography with several tracers to see if imaging can detect inflammation, microcalcification, and clot activity in people with symptomatic peripheral arterial disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh, Midlothian) |
| Trial ID | NCT07472049 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age >18) with symptomatic atherosclerotic peripheral artery disease — including intermittent claudication with ABI <0.90 or >50% stenosis, rest pain, tissue loss, prior revascularization, or amputation — who can give informed consent are ideal candidates.
Not a fit: People without symptomatic PAD, those with contraindications to iodinated contrast or colchicine, or those unable to undergo PET-CT scans are unlikely to benefit from participation.
Why it matters
Potential benefit: If imaging patterns reliably mark high-risk plaque behaviour, clinicians could better target treatments to prevent limb loss, heart attacks, and strokes.
How similar studies have performed: Prior single-tracer PET studies (for example with 18F-NaF and DOTATATE) have shown promise in detecting plaque microcalcification and inflammation, but combining multiple tracers across whole-body vascular beds in PAD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
Edinburgh, Midlothian
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.