A Study on Hemodynamic Relationship Including Cerebral Blood Flow Using Phase Contrast and Signal Intensity Gradient of Brain Magnetic Resonance Imaging, and Carotid Doppler Ultrasound

NCT ID: NCT04585971

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-03

Study Completion Date

2021-01-31

Brief Summary

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Cerebral blood flow measurement, which is applied to patients with cerebrovascular-related diseases, provides useful information about hemodynamic status. There was a method using Doppler ultrasound and phase contrast (PC) MRI, but it was not widely used in clinical practice due to limitations in reproducibility between examiners, complexity of procedure, and time-intensive protocol. We intend to measure cerebral blood flow through the signal-intensity gradient (SIG) technique using Time-of-Flight (TOF) of brain magnetic resonance imaging, which can compensate for the shortcomings of the existing research methods. In addition, by analyzing the correlation with the previous methods, Doppler ultrasound and PC MRI, we will evaluate the effectiveness of our new method.

Detailed Description

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Conditions

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Cerebral Blood Flow

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects

Cerebral blood flow of a subject is measured using three methods in both common carotid and vertebral arteries. 1) Phase-contrast MR 2) Doppler sonography 3) Signal Intensity Gradient (SIG) To determine whether there is a correlation between the measured values, the correlation coefficient is calculated and analyzed.

Signal intensity gradient

Intervention Type DIAGNOSTIC_TEST

Signal intensity gradient:

In time-of-flight (TOF) MRA, The signal intensities at the iso-point (Φa; signal intensity at position A \[Xa\] along the arterial contour line) and at the inner point (Φb; signal intensity at position B \[Xb\]) were calculated by using a trilinear interpolation algorithm based on the positions and signal intensities in the eight neighboring voxels. The signal intensities of TOF-MRA were normalized to eliminate the offset and scale effects across the MRA datasets of participants. For each iso-point (position A), the SIG was calculated from the difference in signal intensities between points A and B as follows:

Scalar SIG, SI/mm = (Φb - Φa) / │Xb - Xa│ (1)

Vector SIG, SI/mm = (Φb - Φa) n / │Xb - Xa│ (2)

Interventions

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Signal intensity gradient

Signal intensity gradient:

In time-of-flight (TOF) MRA, The signal intensities at the iso-point (Φa; signal intensity at position A \[Xa\] along the arterial contour line) and at the inner point (Φb; signal intensity at position B \[Xb\]) were calculated by using a trilinear interpolation algorithm based on the positions and signal intensities in the eight neighboring voxels. The signal intensities of TOF-MRA were normalized to eliminate the offset and scale effects across the MRA datasets of participants. For each iso-point (position A), the SIG was calculated from the difference in signal intensities between points A and B as follows:

Scalar SIG, SI/mm = (Φb - Φa) / │Xb - Xa│ (1)

Vector SIG, SI/mm = (Φb - Φa) n / │Xb - Xa│ (2)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Time-of-flight magnetic resonance imaging Carotid Doppler sonography

Eligibility Criteria

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Inclusion Criteria

1. Patients 18 years of age or older who have been admitted to the neurology department due to a stroke, and those who have already performed brain magnetic resonance imaging
2. Among the patients (1) who underwent carotid artery Doppler ultrasound
3. Patients who fully understand the research objectives and procedures and wish to participate in clinical research voluntarily
4. If a patient is not fully understood due to a decrease in awareness or consciousness, the consent of the legal representative is required

Exclusion Criteria

1. Patients whose extracranial artery occlusion or severe stenosis was confirmed in brain magnetic resonance images.
2. Those who judge that the subject is unsuitable for participation in clinical research due to other reasons.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medi Image, Inc

UNKNOWN

Sponsor Role collaborator

Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chan-Hyuk Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chan-Hyuk Lee, Prof.

Role: PRINCIPAL_INVESTIGATOR

Jeonbuk National University Hospital

Locations

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Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chan-Hyuk Lee, Prof.

Role: CONTACT

+82-063-250-1590

Facility Contacts

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Chan-Hyuk Lee, Prof.

Role: primary

+82-010-2822-9803

References

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Han KS, Lee SH, Ryu HU, Park SH, Chung GH, Cho YI, Jeong SK. Direct Assessment of Wall Shear Stress by Signal Intensity Gradient from Time-of-Flight Magnetic Resonance Angiography. Biomed Res Int. 2017;2017:7087086. doi: 10.1155/2017/7087086. Epub 2017 Aug 16.

Reference Type BACKGROUND
PMID: 28900625 (View on PubMed)

Lee WJ, Jeong SK, Han KS, Lee SH, Ryu YJ, Sohn CH, Jung KH. Impact of Endothelial Shear Stress on the Bilateral Progression of Unilateral Moyamoya Disease. Stroke. 2020 Mar;51(3):775-783. doi: 10.1161/STROKEAHA.119.028117. Epub 2019 Dec 20.

Reference Type BACKGROUND
PMID: 31856692 (View on PubMed)

Jeong SK, Lee JY, Rosenson RS. Association between Ischemic Stroke and Vascular Shear Stress in the Carotid Artery. J Clin Neurol. 2014 Apr;10(2):133-9. doi: 10.3988/jcn.2014.10.2.133. Epub 2014 Apr 23.

Reference Type BACKGROUND
PMID: 24829599 (View on PubMed)

Lee CH, Lee SH, Kwak HS, Kwak YG, Rosenson RS, Cho YI, Jeong SK. Validation of Signal Intensity Gradient from TOF-MRA for Wall Shear Stress by Phase-Contrast MR. J Imaging Inform Med. 2024 Jun;37(3):1248-1258. doi: 10.1007/s10278-024-00991-5. Epub 2024 Feb 8.

Reference Type DERIVED
PMID: 38332403 (View on PubMed)

Other Identifiers

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SIGBF

Identifier Type: -

Identifier Source: org_study_id

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