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Recruiting NCT07472049

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

— Observational Peripheral Arterial Disease Chronic Limb Threatening Ischemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whole body [68Ga]DOTATATE PET-CT, Whole body [18F]GP1 PET-CT, Whole body [18F]NaF PET-CT, Whole body CT angiogram.
Who it may be relevant to
Registry conditions: Peripheral Arterial Disease, Chronic Limb Threatening Ischemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • 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

Primary outcome measures

  • Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s) [Time frame: From baseline imaging until completion imaging at 1 year]
Secondary outcome measures (4)
  • Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in remote arterial territories [Time frame: From baseline imaging until completion imaging at 1 year]
  • CT plaque morphology [Time frame: From baseline imaging to completion imaging at 1 year]
  • The association between patient risk factors for cardiovascular disease and PET tracer uptake [Time frame: Frome baseline imaging to completion imaging at 1 year]
  • The progression of microcalcification, as defined by [18F]NaF uptake, to macrocalcification. [Time frame: From baseline imaging to completion imaging at 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Royal Infirmary of Edinburgh — Edinburgh

Identifiers

NCT: NCT07472049 · AC25008 · BHF PG/24/12097

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗