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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
