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临床试验/NCT03591523
NCT03591523Unknown不适用

Blood Flow Measurement in Cervical and Cerebral Arteries Using Quantitative Magnetic Resonance Angiography and Cervical and Transcranial Duplex Sonography

Palacky University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年8月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
21
试验地点
1
主要终点
Blood flow measurement

研究概览

简要总结

The aim of the study is to assess the correlation of blood flow measurement in cervical and intracranial arteries between quantitative magnetic resonance angiography (qMRA) and duplex sonography (DS) and inter-/intra-investigators reliability of both methods in common clinical practice. A total of 21 subjects indicated to qMRA or DS for suspicion of cervical or intracranial vascular pathology will be included. All patients will undergo qMRA and DS of the cervical and intracranial arteries with measurement of blood flow in bilateral common carotid artery (CCA), internal carotid artery in proximal part distally to carotid bulb (ICA) and in distal carotid siphon (ICA-siphon), external carotid artery (ECA), vertebral artery in V2 (V2-VA) and V4 (V4-VA) segments, middle cerebral artery (MCA), anterior cerebral artery in pre-communicant (ACA1) and post-communicant (ACA2) part, posterior cerebral artery in pre-communicant (PCA1) and post-communicant (PCA2) part and basilar artery (BA) the cerebral artery. Correlations between measurements will be evaluated using Spearman's correlation coefficient or kappa coefficient and inter-class correlation coefficient (ICC).

详细描述

Introduction: Measurement of blood flow in cervical and cerebral arteries is important not only for accurate diagnosis of neurovascular diseases but also for refinement of the indication of invasive treatment. Quantitative MR angiography (qMRA) with NOVA flow analysis system and duplex sonography (DS; duplex sonography of cervical arteries and transcranial color-coded duplex sonography) are non-invasive diagnostics methods which could be used for measurement of blood flow in cervical and intracranial arteries.

Aim: The aim of the study is to assess the correlation of blood flow measurement in cervical and intracranial arteries between qMRA and DS in common clinical practice. The secondary aims are to assess the inter-investigator and intra-investigator correlations of both qMRA and DS in blood flow measurement.

Methods: A total of 21 subjects indicated to qMRA or DS for suspicion of cervical or intracranial vascular pathology will be included.

Inclusion criteria: male or female; age 25 - 70 years; signed informed consent. Exclusion criteria: contraindication to magnetic resonance; uncontrolled involuntary movements; other condition preventing long-term quiet lying.

All patients will undergo qMRA and DS of the cervical and intracranial arteries within 2 hours. The NOVA flow analysis system will calculate blood flow in individual segments. In DS, angle corrected blood flow velocities (peak systolic velocity - PSV, end-diastolic velocity - EDV, mean velocity - Vmean) will be measured in individual segments with measurement of arterial in the B-Mode or Color Mode with automatic calculation of blood flow.

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
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or female
  • age 25 - 70 years
  • suspicion of cervical or intracranial vascular pathology
  • signed informed consent.

排除标准

  • contraindication to magnetic resonance
  • uncontrolled involuntary movements
  • other condition preventing long-term quiet lying.

结局指标

主要结局

Blood flow measurement

时间窗: 6 weeks

Correlation of blood flow measurement between qMRA and DS

次要结局

  • Intra-investigator reliability of quantitative magnetic resonance angiography(6 weeks)
  • Intra-investigator reliability of duplex sonography(6 weeks)
  • Inter-investigator reliability of duplex sonography(6 weeks)

研究者

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

Ing. Irena Jedličková

Study Manager

Palacky University

研究点 (1)

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