UMIN-CTR Clinical Trial

Basic information
Public title	Follow-up study of carotid plaque detected in the brain dock
Acronym	Dock Study
Scientific Title	Follow-up study of carotid plaque detected in the brain dock
Scientific Title:Acronym	Dock Study
Region	Japan

Condition
Condition	Patients found to have carotid atherosclerotic plaque detected by ultrasound
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Follow-up surveillance is conducted for cases with no carotid artery stenosis or mild stenosis due to carotid plaque. This will clarify the natural history of the carotid plaque, and thus appropriate guidance can be given at the time of the brain dock.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patients who visited brain dock conducted at the Yokkaichi Hazu Medical Center Health Management Center between January 1st, 2014 and the approval date, and those who visit the brain dock between the approval date and December 31st, 2018, are targeted. Information regarding carotid ultrasound, head MRI / MRA, age, sex, height, weight, past history (hypertension, diabetes, dyslipidemia, hyperuricemia) and life history (smoking status) are collected.
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	1) Patients who visited the brain dock conducted at Yokkaichi Hazu Medical Center Health Management Center from January 1st, 2014 to the approval date, and patients who is going to visit the brain dock from the date of approval until December 31st, 2018. 2) Among 1), patients with carotid plaque due to atherosclerosis detected by carotid ultrasound.
Key exclusion criteria	1) Refusal in participating in this research is declared by a patient or his/her substitute. 2) Patient who is considered inappropriate as a research subject by researchers. 3) Patients who did not take carotid ultrasound at the brain dock.
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Ryuta Middle name Last name Yasuda
Organization	Mie University Graduate school of Medicine
Division name	Department of Neurosurgery
Zip code	514-8507
Address	2-174 Edobashi, Tsu, Mie 514-0001
TEL	059-232-1111
Email	neurosurgery@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Ryuta Middle name Last name Yasuda
Organization	Mie University Graduate school of Medicine
Division name	Department of Neurosurgery
Zip code	514-8507
Address	2-174 Edobashi, Tsu, Mie 514-0001
TEL	059-232-1111
Homepage URL
Email	neurosurgery@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University
Institute
Department

Funding Source
Organization	Mie University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Mie University Graduate school of Medicine
Address	2-174 Edobashi, Tsu, Mie 514-0001
Tel	059-232-1111
Email	neurosurgery@clin.medic.mie-u.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

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 30 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
Results
Results date posted
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	Terminated
Date of protocol fixation	2018 Year 01 Month 17 Day
Date of IRB	2018 Year 06 Month 21 Day
Anticipated trial start date	2018 Year 06 Month 30 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Follow-up surveillance for each patient is conducted by interview, telephone or written questionnaire and cerebro-/cardio-vascular events, introduction of medical treatment for carotid artery stenosis or surgical intervention are tracked. Patients who visited the brain dock between January 1st, 2014 and the approval date will be investigated five years after the examination by telephone or written questionnaire. Patients who are going to visit the brain dock between the approval date and December 31st, 2018, follow-up surveillance is conducted every 1 year until 5 years after the date of brain dock visit.

Management information
Registered date	2018 Year 06 Month 21 Day
Last modified on	2021 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037724