NCT07472049

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In peripheral arterial disease (PAD), arteries in the lower body can become narrowed and develop blockages due to a process called atherosclerosis, leading to reduced blood flow to the lower limbs. Symptoms can range from mild cramping pain in legs on walking, to loss of parts of the leg. Patients with PAD are also at a high risk of blockages in other arteries in the body that can lead to problems such as heart attacks and strokes. Despite improvements in medical treatments and surgery, the outlook for patients with PAD has not improved. Further information is required to understand the relationships between the processes that lead to narrowing and blockages (atherosclerosis) of the arteries and if they behave the same in different parts of the body. This can help to identify targeted treatments to reduce the risk of the disease getting worse and avoid heart attacks and strokes. In this study investigators plan to recruit 100 people with symptomatic PAD to undergo a series of whole body PET-CT and CT angiogram scans using different tracers targeting the processes involved in atherosclerosis. Investigators will aim to co-enrol patients taking part in the LEADER-PAD study (NCT04774159).

Conditions

• Peripheral Arterial Disease
• Chronic Limb Threatening Ischemia

Interventions

Type	Name	Description
RADIATION	Whole body [68Ga]DOTATATE PET-CT	Targeting vascular inflammation
RADIATION	Whole body [18F]GP1 PET-CT	Targeting thrombus activity
RADIATION	Whole body [18F]NaF PET-CT	Targeting vascular microcalcification
RADIATION	Whole body CT angiogram	To determine anatomical and morphological atherosclerotic plaque characteristics

Timeline

• Start date: 2025-07-31
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: United Kingdom