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Clinical Trials/NCT03591523
NCT03591523
Unknown
Not Applicable

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

Palacky University1 site in 1 country21 target enrollmentAugust 6, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebrovascular Circulation
Sponsor
Palacky University
Enrollment
21
Locations
1
Primary Endpoint
Blood flow measurement
Last Updated
7 years ago

Overview

Brief Summary

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).

Detailed Description

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. The blood flow will be assessed in the following arterial segments: 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. At least 2 patients will undergo qMRA and DS performed by the same investigators twice in the time interval of 2 - 10 days and DS will be performed in all patients by 2 sonographers using 2 different machines for assessment of inter-investigator and intra-investigator reliability. All investigators will be blinded to the diagnosis and measurement performed using other diagnostics method. In all patients will be collecting following data: blood pressure, weight, height, age, gender, time of examination Statistics: Correlations between measurements will be evaluated using Spearman's correlation coefficient or kappa coefficient and inter-class correlation coefficient (ICC).

Registry
clinicaltrials.gov
Start Date
August 6, 2018
End Date
August 31, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ing. Irena Jedličková

Study Manager

Palacky University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Blood flow measurement

Time Frame: 6 weeks

Correlation of blood flow measurement between qMRA and DS

Secondary Outcomes

  • 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)

Study Sites (1)

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