NCT03591523

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

25 days

First QC Date

July 7, 2018

Last Update Submit

August 6, 2018

Conditions

Cerebrovascular Circulation

Keywords

cerebrovascular circulationarterial blood flowmagnetic resonanceduplex sonography

Outcome Measures

Primary Outcomes (1)

  • Blood flow measurement

    Correlation of blood flow measurement between qMRA and DS

    6 weeks

Secondary Outcomes (3)

  • Intra-investigator reliability of quantitative magnetic resonance angiography

    6 weeks

  • Inter-investigator reliability of duplex sonography

    6 weeks

  • Intra-investigator reliability of duplex sonography

    6 weeks

Study Arms (1)

Suspicion of vascular pathology

Subjects indicated to quantitative MR angiography and duplex sonography for suspicion of cervical or intracranial vascular pathology

Diagnostic Test: Quantitative MR angiographyDiagnostic Test: Duplex sonography

Interventions

Quantitative MR angiographyDIAGNOSTIC_TEST

Quantitative MR angiography: A standard axial 3-dimensional time-of-flight (TOF) MRA of intracranial and cervical arteries will be obtained. Then, the acquired images will be transmitted to the workstation to reconstruct 3D surface-rendered vessel images. After determining optimal perpendicular scan plane and setting the baseline coordinates , retrospectively gated, fast 2-dimensional phase-contrast sequence will be performed. Velocity encoding will be automatically adjusted by NOVA software.

Also known as: qMRA
Suspicion of vascular pathology
Duplex sonographyDIAGNOSTIC_TEST

Duplex sonography of cervical arteries will be performed using 5 - 12 MHz linear duplex probe and transcranial color-coded duplex sonography will be performed using 2 - 5 MHz transcranial duplex probe. Peak systolic velocity, end diastolic celocity, mean blood flow velocity and arterial diameter will be measured with automatic calculation of blood flow velocity in each arterial segment.

Also known as: DS
Suspicion of vascular pathology

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects indicated to qMRA or DS for suspicion of cervical or intracranial vascular pathology will be included

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemocnice Ceske Budejovice

České Budějovice, Czechia

RECRUITING

Study Officials

  • David Skoloudik, Prof. Dr.

    Palacký University Olomouc, Center for Science and Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Skoloudik, Prof. Dr.

CONTACT

+420739782970skoloudik@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Manager

Study Record Dates

First Submitted

July 7, 2018

First Posted

July 19, 2018

Study Start

August 6, 2018

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

CZ(1)