Cerebrovascular CirculationNCT03591523
Blood Flow Measurement Using Quantitative Magnetic Resonance Angiography and Duplex Sonography
An observational study of Cerebrovascular Circulation, run by Palacky University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Cerebrovascular Circulation
- What is being tested?
- Quantitative MR angiography and Duplex sonography
- How many people
- 21 participants
- Where
- 1 siteCzechia
- Study dates
- 6 Aug 2018to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects indicated to qMRA or DS for suspicion of cervical or intracranial vascular pathology will be included
Who may be able to join
- male or female
- age 25 - 70 years
- suspicion of cervical or intracranial vascular pathology
- signed informed consent.
Who cannot join
- contraindication to magnetic resonance
- uncontrolled involuntary movements
- other condition preventing long-term quiet lying.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Nemocnice Ceske Budejovice
České Budějovice
Jiří Fiedler, M.D., Ph.D., 00420607868729, fiedler@nemcb.cz
Martin Reiser, M.D., reiser.martin@nemcb.cz
About this study
Official title: 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).
Read the 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).
- Conditions
- Cerebrovascular Circulation
- Being tested
- Quantitative MR angiography, Duplex sonography
- Keywords
- cerebrovascular circulation, arterial blood flow, magnetic resonance, duplex sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative MR angiographyDiagnostic test
Also called qMRA
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.
Duplex sonographyDiagnostic test
Also called DS
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.
| Study group | Role | What they receive |
|---|---|---|
| Suspicion of vascular pathology | Subjects indicated to quantitative MR angiography and duplex sonography for suspicion of cervical or intracranial vascular pathology Receives: Diagnostic Test: Quantitative MR angiography; Diagnostic Test: Duplex sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow measurement
Correlation of blood flow measurement between qMRA and DS
Measured: 6 weeks
Secondary outcomes (3)
Intra-investigator reliability of quantitative magnetic resonance angiography
Intrainvestigator reliability of blood flow measurement using qMRA performed by the same investigators in two sessions
Measured: 6 weeks
Inter-investigator reliability of duplex sonography
Inter-investigator reliability of blood flow measurement using duplex sonography performed by 2 investigators
Measured: 6 weeks
Intra-investigator reliability of duplex sonography
Intra-investigator reliability of blood flow measurement using duplex sonography performed by the same investigator in two sessions
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start6 Aug 2018
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular CirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Collaborators
- České Budějovice Hospital
- Responsible party
- Principal investigator, Ing. Irena Jedličková, Palacky University
- Investigators
- David Skoloudik, Prof. Dr., Principal investigator, Palacký University Olomouc, Center for Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591523
- Sponsor's protocol ID
- 28042018
- Status last verified
- Aug 2018
- First submitted
- 7 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Measurement in Cervical and Cerebral Arteries Using Quantitative Magnetic Resonance Angiography and Cervical and Transcranial Duplex Sonography
- ClinicalTrials.gov ID
- NCT03591523
- Acronym / sponsor ID
- 28042018
- Conditions
- Cerebrovascular Circulation
- Keywords
- cerebrovascular circulation, arterial blood flow, magnetic resonance, duplex sonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Collaborators
- České Budějovice Hospital
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicion of vascular pathology | – | Diagnostic Test: Quantitative MR angiography, Diagnostic Test: Duplex sonographySubjects indicated to quantitative MR angiography and duplex sonography for suspicion of cervical or intracranial vascular pathology |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects indicated to qMRA or DS for suspicion of cervical or intracranial vascular pathology will be included
Key inclusion criteria (4 listed)
- male or female
- age 25 - 70 years
- suspicion of cervical or intracranial vascular pathology
- signed informed consent.
Key exclusion criteria (3 listed)
- contraindication to magnetic resonance
- uncontrolled involuntary movements
- other condition preventing long-term quiet lying.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative MR angiographyAlso: qMRAQuantitative 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. | Diagnostic test | Suspicion of vascular pathology |
| Duplex sonographyAlso: DSDuplex 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. | Diagnostic test | Suspicion of vascular pathology |
Primary outcome
Blood flow measurement
Time frame: 6 weeks
Correlation of blood flow measurement between qMRA and DS
3 secondary outcomes
Intra-investigator reliability of quantitative magnetic resonance angiography
Time frame: 6 weeks
Inter-investigator reliability of duplex sonography
Time frame: 6 weeks
Intra-investigator reliability of duplex sonography
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Skoloudik, Prof. Dr. principal investigator
Palacký University Olomouc, Center for Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Circulation, run by Palacky University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Skoloudik, Prof. Dr. (+420739782970, skoloudik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow measurement (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.