使用新型成像技术对周围动脉疾病患者有症状和系统性动脉粥样硬化斑块活性的研究 (SISYPHUS)
采用新型成像技术对周围动脉疾病患者有症状性和系统性动脉粥样硬化斑块活动的研究
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.
研究概览
地位
详细说明
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).
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Allison c Winarski, MBChB, MRCS(Ed)
- 电话号码：+447495905258
- 邮箱：awinarsk@ed.ac.uk
研究联系人备份
- 姓名：Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
- 电话号码：+44 01312423585
- 邮箱：rachael.forsythe@ed.ac.uk
学习地点
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Midlothian
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Edinburgh、Midlothian、英国、EH16 4SA
- 招聘中
- Royal Infirmary of Edinburgh
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接触：
- Allison C Winarski, MBChB MRSC(Ed)
- 电话号码：+447495905258
- 邮箱：awinarsk@ed.ac.uk
-
接触：
- Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
- 电话号码：01312423585
- 邮箱：rachael.forsythe@ed.ac.uk
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副研究员：
- Allison C Winarski, MBChB MRCS (Ed)
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首席研究员：
- Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
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副研究员：
- David E Newby, BSc (Hons)PhD BM DM DSc FRCP
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients will be prosectively recruited from vascular outpatient clinics and inpatient wards.
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
有症状的周围动脉疾病患者
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Targeting vascular inflammation Targeting thrombus activity Targeting vascular microcalcification To determine anatomical and morphological atherosclerotic plaque characteristics |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s)
大体时间：From baseline imaging until completion imaging at 1 year
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The 3 primary endpoints will be the location and degree of:
|
From baseline imaging until completion imaging at 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in remote arterial territories
大体时间：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
大体时间：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
大体时间：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.
大体时间：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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Major adverse cardiovascular events (MACE) and major adverse limb events (MALE)
大体时间：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
|
合作者和调查者
合作者
调查人员
- 首席研究员：Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)、University of Edinburgh
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- AC25008
- BHF PG/24/12097 (其他赠款/资助编号：British Heart Foundation)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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