Attività della Placca Aterosclerotica Sintomatica e Sistemica nei Pazienti con Malattia Arteriosa Periferica Utilizzando Nuove Tecniche di Imaging (SISYPHUS)
Attività Sintomatica e Sistemica della Placca Aterosclerotica in Pazienti con Malattia Arteriosa Periferica Utilizzando Tecniche di Imaging Innovative
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Allison c Winarski, MBChB, MRCS(Ed)
- Numero di telefono: +447495905258
- Email: awinarsk@ed.ac.uk
Backup dei contatti dello studio
- Nome: Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
- Numero di telefono: +44 01312423585
- Email: rachael.forsythe@ed.ac.uk
Luoghi di studio
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Midlothian
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Edinburgh, Midlothian, Regno Unito, EH16 4SA
- Reclutamento
- Royal Infirmary of Edinburgh
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Contatto:
- Allison C Winarski, MBChB MRSC(Ed)
- Numero di telefono: +447495905258
- Email: awinarsk@ed.ac.uk
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Contatto:
- Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
- Numero di telefono: 01312423585
- Email: rachael.forsythe@ed.ac.uk
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Sub-investigatore:
- Allison C Winarski, MBChB MRCS (Ed)
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Investigatore principale:
- Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
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Sub-investigatore:
- David E Newby, BSc (Hons)PhD BM DM DSc FRCP
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Patients will be prosectively recruited from vascular outpatient clinics and inpatient wards.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Pazienti con malattia arteriosa periferica sintomatica
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Targeting vascular inflammation Targeting thrombus activity Targeting vascular microcalcification To determine anatomical and morphological atherosclerotic plaque characteristics |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in remote arterial territories
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Major adverse cardiovascular events (MACE) and major adverse limb events (MALE)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Rachael O Forsythe, MBChB, PhD, FRCS (Vascular), University of Edinburgh
Studiare le date dei record
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Processi patologici
- Malattia cronica
- Attributi della malattia
- Aterosclerosi
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattie vascolari periferiche
- Ischemia
- Condizioni patologiche, segni e sintomi
- Ischemia cronica minacciosa per gli arti
- Malattia cardiovascolare
- Malattia arteriosa periferica
Altri numeri di identificazione dello studio
- AC25008
- BHF PG/24/12097 (Altro numero di sovvenzione/finanziamento: British Heart Foundation)
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