Atividade Sintomática e Sistémica da Placa Aterosclerótica em Doentes com Doença Arterial Periférica Utilizando Imagiologia Inovadora (SISYPHUS)
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.
Visão geral do estudo
Status
Descrição detalhada
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).
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Allison c Winarski, MBChB, MRCS(Ed)
- Número de telefone: +447495905258
- E-mail: awinarsk@ed.ac.uk
Estude backup de contato
- Nome: Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
- Número de telefone: +44 01312423585
- E-mail: rachael.forsythe@ed.ac.uk
Locais de estudo
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Midlothian
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Edinburgh, Midlothian, Reino Unido, EH16 4SA
- Recrutamento
- Royal Infirmary of Edinburgh
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Contato:
- Allison C Winarski, MBChB MRSC(Ed)
- Número de telefone: +447495905258
- E-mail: awinarsk@ed.ac.uk
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Contato:
- Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
- Número de telefone: 01312423585
- E-mail: rachael.forsythe@ed.ac.uk
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Subinvestigador:
- Allison C Winarski, MBChB MRCS (Ed)
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Investigador principal:
- Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
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Subinvestigador:
- David E Newby, BSc (Hons)PhD BM DM DSc FRCP
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients will be prosectively recruited from vascular outpatient clinics and inpatient wards.
Descrição
Inclusion Criteria:
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Male or female aged > 18 years
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Symptomatic atherosclerotic peripheral artery disease;
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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)
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Rest pain or necrosis of limb or gangrene of limb
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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
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Leg or foot amputation for arterial vascular indications
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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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Pacientes com doença arterial periférica sintomática
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Targeting vascular inflammation Targeting thrombus activity Targeting vascular microcalcification To determine anatomical and morphological atherosclerotic plaque characteristics |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s)
Prazo: From baseline imaging until completion imaging at 1 year
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The 3 primary endpoints will be the location and degree of:
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From baseline imaging until completion imaging at 1 year
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in remote arterial territories
Prazo: From baseline imaging until completion imaging at 1 year
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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. |
From baseline imaging until completion imaging at 1 year
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CT plaque morphology
Prazo: From baseline imaging to completion imaging at 1 year
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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. |
From baseline imaging to completion imaging at 1 year
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The association between patient risk factors for cardiovascular disease and PET tracer uptake
Prazo: Frome baseline imaging to completion imaging at 1 year
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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. |
Frome baseline imaging to completion imaging at 1 year
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The progression of microcalcification, as defined by [18F]NaF uptake, to macrocalcification.
Prazo: From baseline imaging to completion imaging at 1 year
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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. |
From baseline imaging to completion imaging at 1 year
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Major adverse cardiovascular events (MACE) and major adverse limb events (MALE)
Prazo: From baseline imaging to completion imaging at 1 year
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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. |
From baseline imaging to completion imaging at 1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rachael O Forsythe, MBChB, PhD, FRCS (Vascular), University of Edinburgh
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Vasculares
- Processos Patológicos
- Doença crônica
- Atributos da doença
- Aterosclerose
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Doenças Vasculares Periféricas
- Isquemia
- Condições Patológicas, Sinais e Sintomas
- Isquemia Crônica Ameaçadora de Membros
- Doenças cardiovasculares
- Doença arterial periférica
Outros números de identificação do estudo
- AC25008
- BHF PG/24/12097 (Número de outro subsídio/financiamento: British Heart Foundation)
Plano para dados de participantes individuais (IPD)
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