UMIN-ICDS Clinical Trial

Public title

Prospective observational study on hemodynamic analysis using 4D-Flow MRI in patients with cerebral aneurysms and subarachnoid hemorrhage

Acronym

4D-FLASH study

Scientific Title

Prospective observational study on hemodynamic analysis using 4D-Flow MRI in patients with cerebral aneurysms and subarachnoid hemorrhage

Scientific Title:Acronym

4D-FLASH study

Region

Japan

Condition

Cerebral aneurysm, Subarachnoid hemorrhage

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the correlation between hemodynamic parameters (e.g., volume flow rate, flow velocity, wall shear stress) obtained from longitudinal 4D-Flow MRI and the aneurysm occlusion rate or the development and recovery process of cerebral vasospasm in patients treated for unruptured cerebral aneurysms and patients with subarachnoid hemorrhage (SAH).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Correlation between hemodynamic parameters (e.g., WSS, flow velocity) obtained from 4D-Flow MRI and the aneurysm occlusion rate as well as the development and recovery of cerebral vasospasm after SAH.

Key secondary outcomes

1. Presence or absence of perioperative complications in the unruptured cerebral aneurysm group
2. Incidence of delayed cerebral ischemia (DCI) in the SAH group
3. Clinical outcomes (e.g., modified Rankin Scale: mRS) at discharge and 3 months post-operatively

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients scheduled to undergo treatment (e.g., surgical clipping, coil embolization, stent placement) for an unruptured cerebral aneurysm, or patients hospitalized for the treatment of subarachnoid hemorrhage (SAH).
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

100

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

Email

tetsuya7.3wake@gmail.com

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

Email

tetsuya7.3wake@gmail.com

Institute

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital (Clinical Research Promotion Center)

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Email

tetsuya7.3wake@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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, and treatment details.
2. Imaging evaluation (Timing of 4D-Flow MRI acquisition):
- Unruptured cerebral aneurysm group: pre-treatment, post-operative day 1, and 3 months post-operatively.
- SAH group: days 7, 14, 21, and 6 to 12 months after onset.
3. Clinical outcomes: aneurysm occlusion rate, presence and severity of cerebral vasospasm.

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=R000072551