Clinical trial NCT03591523: Blood Flow Measurement Using Quantitative Magnetic Resonance Angiography and Duplex Sonography
Official title: Blood Flow Measurement in Cervical and Cerebral Arteries Using Quantitative Magnetic Resonance Angiography and Cervical and Transcranial Duplex Sonography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Circulation
Keywords: cerebrovascular circulation
arterial blood flow
magnetic resonance
duplex sonography
Lead sponsor: Palacky University
Sponsor class: OTHER
Collaborators: name: České Budějovice Hospital
First posted: 2018-07-19
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects indicated to qMRA or DS for suspicion of cervical or intracranial vascular pathology will be included

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).

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.

Primary outcomes:
measure: Blood flow measurement
timeFrame: 6 weeks
Secondary outcomes:
measure: Intra-investigator reliability of quantitative magnetic resonance angiography
timeFrame: 6 weeks
measure: Inter-investigator reliability of duplex sonography
timeFrame: 6 weeks
measure: Intra-investigator reliability of duplex sonography
timeFrame: 6 weeks
Other outcomes:
Locations:
city: České Budějovice
country: Czechia
facility: Nemocnice Ceske Budejovice
Study officials:
affiliation: Palacký University Olomouc, Center for Science and Research
name: David Skoloudik, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: