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临床试验/NCT02436967
NCT02436967已完成不适用

Classification of Carotid Plaque With Computed Tomography With Fast kVp-switching Technique: A Comparison With Histology and 3-Tesla MRI

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology

研究概览

简要总结

Classification of carotid plaque vessel wall changes in carotid stenosis accordingly to AHA classification (American Heart Association)- comparison between histology and CT. The CT is performed with a fast kVp-switching dual energy technique.

To compare the ability to detect iodine contrast enhancement in the carotid plaque compared with 3T MRI with gadolinium.

详细描述

Patients planned for CEA (carotid endarterectomy) due to carotid stenosis will be examined with one extra CT and MRI before surgery. The CEA specimen is stored in the BiKE-registry (a biobank of operated carotid plaque at the Karolinska Institute). In that registry the patients will be given a personal code which is used to identify the CT, MRI and histology data further on.

Approved by regional ethical review board in Stockholm and local radiation comity at Karolinska University Hospital Solna (Dnr K2435-2014). Informed consent from the participating patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • 50% stenosis (NASCET) or more based on CTA (CT-angiography),
  • MRI or US,
  • Scheduled for CEA
  • 50 years or older,
  • Normal kidney function (estimated GFR (glomerular filtration rate) 60 ml/min or more).

排除标准

  • Contraindications to iodine contrast media,
  • Contraindications to MRI or gadolinium contrast media.

结局指标

主要结局

Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology

时间窗: 4 weeks

The time between radiological examination, surgery and histological analysis is usually approximately 4 weeks

次要结局

  • Comparison between the ability to detect contrast enhancement in the carotid plaque: Fast kVp-switching CT vs 3T MRI(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Staffan Holmin

Professor in clinical neuroimaging

Karolinska Institutet

研究点 (1)

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