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NCT07472049
Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
Conditions: Peripheral Arterial Disease, Chronic Limb Threatening Ischemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: University of Edinburgh
Location: Royal Infirmary of Edinburgh Edinburgh Midlothian
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 \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 (\
Source: ClinicalTrials.gov (NCT07472049). StuddyBuddy aggregates publicly available trial information.