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临床试验/NCT02321410
NCT02321410已完成不适用

Plaque Neovascularization Assessment by Contrast Ultrasounds and Plaque Magnetic Resonance: "in Vivo" Comparison in Human Carotid Atherosclerosis

Ospedale San Giovanni Bellinzona2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Plaque neovascularization grading and quantification (assessment by DCE-MRI)

研究概览

简要总结

Atherosclerosis may initiate early in life and takes years to progress. This contrasts to the abrupt coronary or cerebrovascular events occurring following the transition from a stable to an unstable atherosclerotic plaque. The causes of this discontinuity of the disease are complex and probably multiple. There is increasing evidence that, besides inflammation, neovascularisation of atherosclerotic plaques and intra-plaque hemorrhages play an important role in plaque instability ending-up frequently in acute thrombotic occlusion or distal embolisation of athero-thrombotic material associated with heart attack or stroke. Contrast-enhanced Ultrasound, is a bed-side non-invasive technique, which allows to enhance microvascular structures and to visualize the adventitia and intraplaque vascularization. Dynamic contrast-enhanced plaque MRI (DCE-MRI) which has also been evaluated for in vivo detection and quantification of plaque neovascularity. Together with the presence of a large lipid-rich core, thin fibrous cap, positive remodeling and active inflammatory infiltrate, plaque neovascularisation is considered a valid marker of high-risk (or vulnerable) plaque as demonstrated in histopathological studies using microvessel density.

Aim of the study is to assess and validate the value of contrast enhanced ultrasound (CEUS), a bed-side technique, in detecting plaque neovascularisation and compare it with the quantitative assessment by DCE-MRI in carotis atherosclerosis.

A group of 30 patients with asymptomatic carotid atherosclerosis (> 50% stenosis on Doppler ultrasound) will undergo Carotid Duplex ultrasounds and CEUS. High-resolution plaque MRI and DCE-MRI will be performed in the same patients and will be analyzed by two separate operators blinded to the results of the CEUS in order to detect the efficacy of CEUS when compared with in vivo DCE-MRI, as the standard of reference.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Asymptomatic 50-70% carotid artery stenosis on Doppler ultrasound
  • Asymptomatic >70% carotid artery stenosis on Doppler ultrasound (no surgical indication)
  • Signed informed consent

排除标准

  • Non atherosclerotic occlusive disease
  • Prior carotid endarterectomy on the site of the index carotid artery
  • Contraindications for MRI and CE MRI (history of hypersensitivity to gadolinium salt, pacemaker or vascular clip implantation, implantation of any metallic device, severe claustrophobic reactions)
  • Contraindications to CEUS (hypersensitivity to Sonovue compounds, acute coronary syndromes, acute heart failure, heart failure in NYHA class III or IV, severe arrhythmias, known right-to-left cardiac shunt, severe pulmonary hypertension, uncontrolled arterial hypertension, acute distress respiratory syndrome)
  • Short-term life-threatening pathology (life expectancy < 6 months)
  • Physically unable to participate in the study
  • Compliance not guaranteed
  • Pregnancy

研究组 & 干预措施

Imaging of carotid plaque

Other

Patient undergo contrast enhanced ultrasound of the carotid plaque and dynamic contrast-enhanced carotid plaque MRI

干预措施: Contrast enhanced ultrasound of the carotid plaque (Other)

Imaging of carotid plaque

Other

Patient undergo contrast enhanced ultrasound of the carotid plaque and dynamic contrast-enhanced carotid plaque MRI

干预措施: Dynamic contrast-enhanced carotid plaque MRI (Other)

结局指标

主要结局

Plaque neovascularization grading and quantification (assessment by DCE-MRI)

时间窗: Baseline

Contrast enhanced ultrasound plaque neovascularization grading , correlated to plaque neovascularization quantitative assessment by DCE-MRI.

次要结局

未报告次要终点

研究者

发起方
Ospedale San Giovanni Bellinzona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Augusto Gallino

Professor MD

Ospedale San Giovanni Bellinzona

研究点 (2)

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