UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of thoracic aorta surgery on cerebral blood flow
Title of the study (Brief title)	Effect of thoracic aorta surgery on cerebral blood flow
Region	Japan

Condition
Condition	thoracic aorta disease
Classification by specialty	Vascular surgery Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate cerebral blood flow rate change after thoracic aorta surgery.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Volume flow rate change in the bilateral internal and the bilateral vertebral arteries.
Key secondary outcomes

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	Patients who are planned to undergo thoracic aorta surgery
Key exclusion criteria	Who are contraindicated for magnetic resonance imaging
Target sample size	30

Research contact person
Name of lead principal investigator	Hisashi Tanaka
Organization	Osaka University Medical Hospital
Division name	Department of Radiology
Address	Yamadaoka 2-2, Suita, Osaka 565-0871, Japan
TEL	+81668793434
Email	tanaka@radiol.med.osaka-u.ac.jp

Public contact
Name of contact person	Hisashi Tanaka
Organization	Osaka University Medical Hospital
Division name	Department of Radiology
Address	Yamadaoka 2-2, Suita, Osaka 565-0871, Japan
TEL	+81668793434
Homepage URL
Email	tanaka@radiol.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Medical Hospital
Institute
Department

Funding Source
Organization	Osaka University Medical Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 11 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To measure cerebral blood flow with magnetic resonance imaging.

Management information
Registered date	2016 Year 10 Month 24 Day
Last modified on	2016 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028239