UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033081
Receipt number R000037724
Scientific Title Follow-up study of carotid plaque detected in the brain dock
Date of disclosure of the study information 2018/06/30
Last modified on 2021/12/23 13:55:36

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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 or person

Institute

Mie University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037724


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name