UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063384 |
|---|---|
| Receipt number | R000072552 |
| Scientific Title | Prospective observational study on cerebral hyperperfusion and hemodynamics before and after carotid revascularization (CAS/CEA) for carotid artery stenosis: A comparative study of 4D-Flow MRI and SPECT |
| Date of disclosure of the study information | 2026/10/23 |
| Last modified on | 2026/10/23 11:02:50 |
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Basic information
Public title
Prospective observational study on cerebral hyperperfusion and hemodynamics before and after carotid revascularization (CAS/CEA) for carotid artery stenosis: A comparative study of 4D-Flow MRI and SPECT
Acronym
4D-CHART study
Scientific Title
Prospective observational study on cerebral hyperperfusion and hemodynamics before and after carotid revascularization (CAS/CEA) for carotid artery stenosis: A comparative study of 4D-Flow MRI and SPECT
Scientific Title:Acronym
4D-CHART study
Region
| Japan |
Condition
Condition
Carotid artery stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients undergoing CAS or CEA for carotid artery stenosis, 4D-Flow MRI (total of 4 times) and SPECT (total of 2 times) will be performed before and after treatment. Using the evaluation of cerebral blood flow and hyperperfusion by SPECT before surgery and on post-operative day 1 as the reference standard, this study aims to clarify how hemodynamic parameters from concurrently acquired 4D-Flow MRI correlate with SPECT findings. Furthermore, by analyzing 4D-Flow MRI on post-operative day 7 and at 3 months, we will elucidate the persistence of hyperperfusion and the process (timing) of hemodynamic stabilization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the presence or absence of hyperperfusion on SPECT on post-operative day 1 and hemodynamic parameters (e.g., WSS, flow velocity, volume flow rate) obtained from 4D-Flow MRI at the same timepoint.
Key secondary outcomes
1. Longitudinal changes in hemodynamic parameters on 4D-Flow MRI before treatment, on post-operative days 1 and 7, and at 3 months post-operatively (investigation of the persistence and recovery timing of hyperperfusion)
2. Incidence of perioperative complications such as symptomatic cerebral hyperperfusion syndrome (CHS) and cerebral ischemia
3. Clinical outcomes (e.g., modified Rankin Scale: mRS) at discharge and 3 months post-operatively
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo CAS or CEA for carotid artery stenosis.
2. Patients from whom written informed consent for participation in this study has been obtained from the patient themselves or a legally acceptable representative.
Key exclusion criteria
1. Patients with contraindications to MRI examination (e.g., metallic implants, claustrophobia).
2. Patients judged by the attending physician to have difficulty remaining still during MRI acquisition due to severe disturbance of consciousness or restlessness.
3. Other patients judged by the principal investigator or attending physician to be inappropriate as study subjects.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Tsukada |
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Division name
Department of Neurosurgery
Zip code
4668650
Address
2-9 Myoken-cho, Showa-ku, Nagoya-shi, Aichi
TEL
0528321121
tetsuya7.3wake@gmail.com
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Tsukada |
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Division name
Department of Neurosurgery
Zip code
4668650
Address
2-9 Myoken-cho, Showa-ku, Nagoya-shi, Aichi
TEL
0528321121
Homepage URL
tetsuya7.3wake@gmail.com
Sponsor or person
Institute
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital (Clinical Research Promotion Center)
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital (Clinical Research Promotion Center)
Address
2-9 Myoken-cho, Showa-ku, Nagoya, Aichi 466-8650, Japan
Tel
052-832-1121
tetsuya7.3wake@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Study Design] A prospective observational study in which a 4D-Flow MRI sequence for research is added to routine clinical MRI examinations.
[Survey Items]
1. Baseline characteristics: age, sex, medical history, diagnosis, stenosis rate and flow velocity obtained from carotid ultrasound findings, and treatment details (CAS or CEA).
2. Timing of imaging evaluation:
- 4D-Flow MRI: pre-treatment, post-operative day 1, post-operative day 7, and 3 months post-operatively (total of 4 times).
- SPECT: pre-treatment and post-operative day 1 (total of 2 times).
3. Clinical outcomes: presence or absence of hyperperfusion on SPECT, incidence of symptomatic cerebral hyperperfusion syndrome (CHS), and perioperative complications.
Management information
Registered date
| 2026 | Year | 10 | Month | 23 | Day |
Last modified on
| 2026 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072552
