Tokyo, Oct. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063384) titled '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' on Oct. 23.

Study Type: Observational

Primary Sponsor: Institute - Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital (Clinical Research Promotion Center)

Condition: Condition - Carotid artery stenosis Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 50

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=R000072552

Disclaimer: Curated by HT Syndication.