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UMIN ID: UMIN000054214

Registered date:22/04/2024

Quantifying Brain Oxygenation Index for Thrombectomy Outcome Assessment Study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Patients undergoing endovascular reperfusion therapy for cerebral infarction due to acute occlusion of the main cerebral artery (internal carotid artery or middle cerebral artery)
Date of first enrollment	2023/08/17
Target sample size	100
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

TO Original Data: UMIN

Outcome(s)

Primary Outcome	Relationship between TD-NIRS measurements and cases of functional independence (modified Rankin Scale 0-2) after 3 months in effective reperfusion cases
Secondary Outcome	Relationship between TD-NIRS measurements and Preoperative ischemia severity (NIHSS) Ischemic core volume and penumbra volume and their ratio on preoperative CT perfusion imaging Percentage of good collateral perfusion on preoperative CT angiography and cerebral angiography Degree of reperfusion (expanded TICI grade) and presence of early venous drainage on cerebral angiography at the end of the procedure Number of procedures performed in patients with complete reperfusion on cerebral angiography Ischemic core volume and penumbra volume and their ratios in the immediate postoperative CT perfusion images Infarct expansion within 24 hours after surgery Symptomatic intracranial hemorrhage within 24 hours after surgery Early improvement of neurological symptoms within 24 hours after surgery

Primary Outcome

Relationship between TD-NIRS measurements and cases of functional independence (modified Rankin Scale 0-2) after 3 months in effective reperfusion cases

Secondary Outcome

Relationship between TD-NIRS measurements and Preoperative ischemia severity (NIHSS) Ischemic core volume and penumbra volume and their ratio on preoperative CT perfusion imaging Percentage of good collateral perfusion on preoperative CT angiography and cerebral angiography Degree of reperfusion (expanded TICI grade) and presence of early venous drainage on cerebral angiography at the end of the procedure Number of procedures performed in patients with complete reperfusion on cerebral angiography Ischemic core volume and penumbra volume and their ratios in the immediate postoperative CT perfusion images Infarct expansion within 24 hours after surgery Symptomatic intracranial hemorrhage within 24 hours after surgery Early improvement of neurological symptoms within 24 hours after surgery

Key inclusion & exclusion criteria

Age minimum	18years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	Patients who satisfy the following (1) or (2) (1) Patients who are currently participating in another clinical trial (2) Patients who are judged by the physician to be unsuitable for the clinical trial (3) Pregnant patients

Related Information

Primary Sponsor	Kyoto Prefectural University of Medicine
Secondary Sponsor	National Hospital Organization Maizuru Medical Center, Japanese Red Cross Kyoto Daini Hospital
Source(s) of Monetary Support	Kyoto Health Management Research Foundation
Secondary ID(s)

Contact

public contact
Name	Daisuke Maruyama
Address	465 Kajii-cho, Kawaramachi-Hirokouji, Kamigyo-ku, Kyoto Japan 602-8566
Telephone	075-251-5541
E-mail	dmaruyam@koto.kpu-m.ac.jp
Affiliation	Kyoto Prefectural University of Medicine Neurosurgery
scientific contact
Name	Naoya Hashimoto
Address	465 Kajii-cho, Kawaramachi-Hirokouji, Kamigyo-ku, Kyoto Japan
Telephone	075-251-5541
E-mail	nhashimo@koto.kpu-m.ac.jp
Affiliation	Kyoto Prefectural University of Medicine Neurosurgery

TO Original Data: UMIN