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

ConditionsPeripheral Arterial DiseaseChronic Limb Threatening Ischemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Edinburgh

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Patients will be prosectively recruited from vascular outpatient clinics and inpatient wards.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Whole body [68Ga]DOTATATE PET-CT

    Radiation

    Targeting vascular inflammation

  • Whole body [18F]GP1 PET-CT

    Radiation

    Targeting thrombus activity

  • Whole body [18F]NaF PET-CT

    Radiation

    Targeting vascular microcalcification

  • Whole body CT angiogram

    Radiation

    To determine anatomical and morphological atherosclerotic plaque characteristics

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients with symptomatic peripheral arterial disease4 interventions

Trial outcomes

Primary outcomes

1

Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s)

The 3 primary endpoints will be the location and degree of: 1. inflammation: uptake of \[68Ga\]DOTATATE 2. calcification: uptake of \[18F\]NaF 3. thrombus activity: uptake of \[18F\]GP1 in peripheral arterial disease affecting the lower limbs. This will be determined by the degree of tracer standardised uptake values (SUVs) at the site of the symptomatic atherosclerotic plaque.

Time frame
From baseline imaging until completion imaging at 1 year

Secondary outcomes

1

Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in remote arterial territories

The secondary outcome measures will be the location and degree of inflammation, calcification and thrombus activity in remote arterial territories, including the coronary arteries, cerebral arteries, aorta and mesenteric vessels, as determined by SUVs of \[68Ga\]DOTATATE, \[18F\]NaF and \[18F\]GP1, respectively.

Time frame
From baseline imaging until completion imaging at 1 year
2

CT plaque morphology

Investigators will characterise CT plaque morphology (total, calcified, non-calcified and low-attenuation plaque) in peripheral and systemic arterial beds and compare this to areas of \[68Ga\]DOTATATE, \[18F\]GP1 and \[18F\]NaF uptake.

Time frame
From baseline imaging to completion imaging at 1 year
3

The association between patient risk factors for cardiovascular disease and PET tracer uptake

Investigators will explore the association between patient risk factors for cardiovascular disease (hypertension, diabetes, smoking) and the degree of \[68Ga\]DOTATATE, \[18F\]GP1 and \[18F\]NaF uptake as quantified by standard uptake values (SUVs). This will be measured by odds ratio (OR) with 95% confidence interval (CI) for each risk factor-tracer combination.

Time frame
Frome baseline imaging to completion imaging at 1 year
4

The progression of microcalcification, as defined by [18F]NaF uptake, to macrocalcification.

Investigators will also aim to characterise the relationship between microcalcification progressing to calcification and the uptake of \[18F\]NaF. This will be assessed using baseline and follow-up \[18F\]NaF PET-CT SUVs and their correlation with calcified regions on CT angiography.

Time frame
From baseline imaging to completion imaging at 1 year

Other outcomes

1

Major adverse cardiovascular events (MACE) and major adverse limb events (MALE)

Exploratory endpoints will include major adverse cardiovascular events (acute myocardial infarction, stroke or cardiovascular death) and major adverse limb events (revascularisation or lower limb amputation) as well as death from any cause.

Time frame
From baseline imaging to completion imaging at 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Edinburgh

Lead sponsor

NHS Lothian

Collaborator

Source ClinicalTrials.gov
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