UMIN-CTR Clinical Trial

Basic information
Public title	Mild, but Unstable Stenosis of Internal Carotid Artery (MUSIC) Study
Acronym	MUSIC Study
Scientific Title	Mild, but Unstable Stenosis of Internal Carotid Artery (MUSIC) Study
Scientific Title:Acronym	MUSIC Study
Region	Japan

Condition
Condition	Mild (<50%) cervical carotid artery stenosis
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is aimed to clarify the following issues: 1) pathophysiological mechanism of the onset of TIA/ischemic stroke in patients with mild (<50%) carotid stenosis. 2) the incidence of the patients refractory to the best medical treatment due to mild (<50%) carotid stenosis. 3) clinical and radiological characteristics of the patients refractory to the best medical treatment due to mild (<50%) carotid stenosis. 4) the benefits of carotid endarterectomy for the patients refractory to the best medical treatment due to mild (<50%) carotid stenosis.
Basic objectives2	Others
Basic objectives -Others	There is no previous study that denote the utility of modern plaque imaging to identify the risk for recurrent ischemic stroke in patients with mild carotid artery stenosis.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the incidence of recurrent ipsilateral ischemic stroke and the duration until recurrent ipsilateral ischemic stroke
Key secondary outcomes	1) the duration until all recurrent ischemic stroke 2) the duration until ipsilateral and all recurrent TIA 3) the duration until ipsilateral and all recurrent amaurosis fugax 4) the duration until ipsilateral and all retinal artery occlusion 5) the duration until all stroke 6) the duration until all death 7) the incidence of de novo silent cerebral infarct within one and two years 8) the incidence of the progression of carotid artery stenosis within one and two years

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	1) 20 years old or older 2) developed TIA, ischemic stroke, or retinal ischemia in the ipsilateral carotid territory 3) mild (<50%) stenosis in the ipsilateral cervical carotid artery 4) modified Rankin scale; 0, 1, or 2 5) posible to follow up at the outpatient clinic 6) completed informed consent
Key exclusion criteria	1) severe comorbid 2) impossible to perform MR examination 3) pregnant or nursing woman 4) judged as inappropriate by the doctor-in-charge
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Kuroda
Organization	University of Toyama
Division name	Department of Neurosurgery
Zip code	930-0194
Address	2630 Sugitani, Toyama 930-0194, Japan
TEL	076-434-7348
Email	skuroda@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Kuroda
Organization	University of Toyama
Division name	Department of Neurosurgery
Zip code	930-0194
Address	2630 Sugitani, Toyama 930-0194, Japan
TEL	076-434-7348
Homepage URL
Email	skuroda@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	University of Toyama
Address	2630 Sugitani, Toyama 930-0194, Japan
Tel	076-434-7152
Email	ekatarin@med.u-toyama.ac.jp

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

1. 主任研究者 　黒田　敏（富山大学脳神経外科） 2. プロトコール策定委員会 　宇野昌明　（川崎医科大学脳神経外科） 　小笠原邦昭（岩手医科大学脳神経外科） 　佐々木真理（岩手医科大学放射線科） 　黒田　敏　（富山大学脳神経外科） 3.　画像判定委員会 　宇野昌明　（川崎医科大学脳神経外科） 　小笠原邦昭（岩手医科大学脳神経外科） 　黒田　敏　（富山大学脳神経外科） 　吉村紳一　（兵庫医科大学脳神経外科） 　森岡基浩　（久留米大学脳神経外科） 　吉田和道　（京都大学脳神経外科） 4.　統計解析委員 　折笠秀樹　（富山大学バイオ統計学・臨床疫学） 5. 安全監視委員会 　小川　彰　（岩手医科大学） 　橋本信夫　（神戸市民病院機構） 6. 研究参加施設と研究責任医師 　宝金清博　（北海道大学脳神経外科） 　上山憲司　（中村記念病院脳神経外科） 　吉本哲之　（柏葉脳神経外科病院） 　瀧澤克己　（旭川赤十字病院脳神経外科） 　新谷好正　（小樽市立病院脳神経外科） 　小笠原邦昭（岩手医科大学脳神経外科） 　冨永悌二　（東北大学脳神経外科） 　師井淳太　（秋田県立脳血管研究センター） 　塩川芳昭　（杏林大学脳神経外科） 　森　健太郎（防衛医科大学脳神経外科） 　木内博之　（山梨大学脳神経外科） 　黒田　敏　（富山大学脳神経外科） 　堀恵美子　（済生会富山病院脳神経外科） 　岩間　亨　（岐阜大学脳神経外科） 　間瀬光人　（名古屋市立大学脳神経外科） 　宮本　享　（京都大学脳神経外科） 　吉村紳一　（兵庫医科大学脳神経外科） 　沈　正樹　（倉敷中央病院脳神経外科） 　宇野昌明　（川崎医科大学脳神経外科） 　高橋　淳　（国立循環器病研究センター脳神経外科） 　甲村英二　（神戸大学脳神経外科） 　坂井信幸　（神戸市立医療センター中央市民病院脳神経外科） 　永廣信治　（徳島大学脳神経外科） 　國枝武治　（愛媛大学脳神経外科） 　飯原弘二　（九州大学脳神経外科） 　井上　亨　（福岡大学脳神経外科） 　森岡基浩　（久留米大学脳神経外科） 　出雲　剛　（長崎大学脳神経外科）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	109
Results	Not yet
Results date posted	2020 Year 08 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 04 Day
Date of IRB	2016 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2016 Year 08 Month 15 Day
Last modified on	2021 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027220