UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Identification of high-risk carotid plaque characteristics using in vivo 3T MR imaging.
Title of the study (Brief title)	Identification of high-risk carotid plaque characteristics using in vivo 3T MR imaging.
Region	Japan

Condition
Condition	Carotid artery stenosis
Classification by specialty	Medicine in general Cardiology Neurology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The main purpose of this study is to reveal high-risk carotid plaque characteristics for Japanese patients with carotid atherosclerotic disease using in vivo 3T MRI. First, we will compare carotid plaque characteristics between symptomatic and asymptomatic carotid stenosis. Second, we will follow up patients with asymptomatic carotid stenosis and examine the relationship between carotid plaque features and future celebrovascular ischemic events.
Basic objectives2	Others
Basic objectives -Others	Diagnosis of carotid disease.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To compare differences of carotid plaque features between symptomatic and asymptomatic carotid atherosclerosis.
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	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with more than 50% carotid stenosis as measured by ultrasound.
Key exclusion criteria	Patients with contraindication for MRI examination.
Target sample size	200

Research contact person
Name of lead principal investigator	Hideki Ota
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Diagnostic Radiology
Address	1-1 Seiryo-machi, Aoba, Sendai, Miyagi, Japan
TEL	022-717-7312
Email	h-ota@rad.med.tohoku.ac.jp

Public contact
Name of contact person	Hideki Ota
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Diagnostic Radiology
Address	1-1 Seiryo Aoba Sendai
TEL	022-717-7312
Homepage URL
Email	h-ota@rad.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	2011 Year 06 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 25 Day
Anticipated trial start date	2011 Year 08 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	The purpose of this observational study was to evaluate carotid plaque characteristics using 3 Tesla MRI in Japanese population.

Management information
Registered date	2011 Year 06 Month 23 Day
Last modified on	2017 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006904