Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
Patients with symptomatic peripheral arterial disease
干预措施: Whole body CT angiogram (Radiation)
Patients with symptomatic peripheral arterial disease
干预措施: Whole body [68Ga]DOTATATE PET-CT (Radiation)
Patients with symptomatic peripheral arterial disease
干预措施: Whole body [18F]GP1 PET-CT (Radiation)
Patients with symptomatic peripheral arterial disease
干预措施: Whole body [18F]NaF PET-CT (Radiation)
结局指标
主要结局
Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s)
时间窗: From baseline imaging until completion imaging at 1 year
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.
次要结局
- Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in remote arterial territories(From baseline imaging until completion imaging at 1 year)
- CT plaque morphology(From baseline imaging to completion imaging at 1 year)
- The association between patient risk factors for cardiovascular disease and PET tracer uptake(Frome baseline imaging to completion imaging at 1 year)
- The progression of microcalcification, as defined by [18F]NaF uptake, to macrocalcification.(From baseline imaging to completion imaging at 1 year)