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Blood Flow Measurement Using Quantitative Magnetic Resonance Angiography and Duplex Sonography

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ClinicalTrials.gov Identifier: NCT03591523
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
České Budějovice Hospital
Information provided by (Responsible Party):
Ing. Irena Jedličková, Palacky University

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).

Condition or disease Intervention/treatment
Cerebrovascular Circulation Diagnostic Test: Quantitative MR angiography Diagnostic Test: Duplex sonography

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).


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Study Type : Observational
Estimated Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Flow Measurement in Cervical and Cerebral Arteries Using Quantitative Magnetic Resonance Angiography and Cervical and Transcranial Duplex Sonography
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: 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 Name: DS




Primary Outcome Measures :
  1. Blood flow measurement [ Time Frame: 6 weeks ]
    Correlation of blood flow measurement between qMRA and DS


Secondary Outcome Measures :
  1. 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

  2. Inter-investigator reliability of duplex sonography [ Time Frame: 6 weeks ]
    Inter-investigator reliability of blood flow measurement using duplex sonography performed by 2 investigators

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects indicated to qMRA or DS for suspicion of cervical or intracranial vascular pathology will be included
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591523


Contacts
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Contact: David Skoloudik, Prof. Dr. +420739782970 skoloudik@hotmail.com

Locations
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Czechia
Nemocnice Ceske Budejovice Recruiting
České Budějovice, Czechia
Contact: Jiří Fiedler, M.D., Ph.D.    00420607868729    fiedler@nemcb.cz   
Contact: Martin Reiser, M.D.       reiser.martin@nemcb.cz   
Sponsors and Collaborators
Palacky University
České Budějovice Hospital
Investigators
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Principal Investigator: David Skoloudik, Prof. Dr. Palacký University Olomouc, Center for Science and Research

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Responsible Party: Ing. Irena Jedličková, Study Manager, Palacky University
ClinicalTrials.gov Identifier: NCT03591523     History of Changes
Other Study ID Numbers: 28042018
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ing. Irena Jedličková, Palacky University:
cerebrovascular circulation
arterial blood flow
magnetic resonance
duplex sonography