Blood Flow Measurement Using Quantitative Magnetic Resonance Angiography and Duplex Sonography

August 6, 2018 updated by: Ing. Irena Jedličková, Palacky University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • České Budějovice, Czechia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 angiography
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.
Other Names:
  • qMRA
Diagnostic test: Duplex sonography
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.
Other Names:
  • DS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow measurement
Time Frame: 6 weeks
Correlation of blood flow measurement between qMRA and DS
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-investigator reliability of quantitative magnetic resonance angiography
Time Frame: 6 weeks
Intrainvestigator reliability of blood flow measurement using qMRA performed by the same investigators in two sessions
6 weeks
Inter-investigator reliability of duplex sonography
Time Frame: 6 weeks
Inter-investigator reliability of blood flow measurement using duplex sonography performed by 2 investigators
6 weeks
Intra-investigator reliability of duplex sonography
Time Frame: 6 weeks
Intra-investigator reliability of blood flow measurement using duplex sonography performed by the same investigator in two sessions
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palacky University

Collaborators

České Budějovice Hospital

Investigators

  • Principal Investigator: David Skoloudik, Prof. Dr., Palacký University Olomouc, Center for Science and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Anticipated)

August 31, 2018

Study Completion (Anticipated)

August 31, 2018

Study Registration Dates

First Submitted

July 7, 2018

First Submitted That Met QC Criteria

July 7, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 28042018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebrovascular Circulation

Clinical Trials on Quantitative MR angiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe