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

October 13, 2020 updated by: Chan-Hyuk Lee, Chonbuk National University Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

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

Study Contact

Study Locations

    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Recruiting
        • Jeonbuk National University Hospital
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the neurology department of a tertiary center

Description

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.

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: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:

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)

Other Names:
  • Time-of-flight magnetic resonance imaging
  • Carotid Doppler sonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral blood flow correlation
Time Frame: After completion of recruitment, average 1 year
Cerebral blood flow correlation between 3 tests (SIG, PC MR, US)
After completion of recruitment, average 1 year

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Chan-Hyuk Lee, Prof., Jeonbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

September 3, 2020

Primary Completion (Anticipated)

January 31, 2021

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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 Cerebral Blood Flow

Clinical Trials on Signal intensity gradient

3
Subscribe