Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Dis… (NCT07472049) | Clinical Trial Compass
RecruitingNot Applicable
Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
United Kingdom100 participantsStarted 2025-07-31
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 azithrom…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s)
Timeframe: From baseline imaging until completion imaging at 1 year