NCT07472049 Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
| NCT ID | NCT07472049 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-07-31 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
PRINCIPAL INVESTIGATOR
University of Edinburgh
Frequently Asked Questions
Who can join the NCT07472049 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07472049 currently recruiting?
Yes, NCT07472049 is actively recruiting participants. Contact the research team at awinarsk@ed.ac.uk for enrollment information.
Where is the NCT07472049 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT07472049 clinical trial?
NCT07472049 is sponsored by University of Edinburgh. The principal investigator is Rachael O Forsythe, MBChB, PhD, FRCS (Vascular) at University of Edinburgh. The trial plans to enroll 100 participants.