Tokyo, Oct. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063383) titled 'Prospective observational study on hemodynamic analysis using 4D-Flow MRI in patients with cerebral aneurysms and subarachnoid hemorrhage' on Oct. 23.
Study Type:
Observational
Primary Sponsor:
Institute - Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital (Clinical Research Promotion Center)
Condition:
Condition - Cerebral aneurysm, Subarachnoid hemorrhage
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072551
Disclaimer: Curated by HT Syndication.