UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030332 |
|---|---|
| Receipt number | R000034452 |
| Scientific Title | NHO Microbleeds in relationship to antithrombotic agents study |
| Date of disclosure of the study information | 2017/12/10 |
| Last modified on | 2018/09/25 21:17:44 |
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Basic information
Public title
NHO Microbleeds in relationship to antithrombotic agents study
Acronym
NOBLESSE study
Scientific Title
NHO Microbleeds in relationship to antithrombotic agents study
Scientific Title:Acronym
NOBLESSE study
Region
| Japan |
Condition
Condition
Ischemic stroke
Classification by specialty
| Cardiology | Neurology | Geriatrics |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether progression of cerebral microbleeds is related to the types of antithrombotic agents in patients with ischemic stroke.
Basic objectives2
Others
Basic objectives -Others
The relationship between progression of cerebral microbleeds and the types of antithrombotic agents.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numbers of cerebral microbleeds signal on T2*-weighted gradient-echo
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
(1) Ischemic stroke patients who take antithrombotic agent within three months of the ischemic stroke onset
(2) 20 years and over at the time of entry
(3) Male and Female
(4) Patients who are able to receive MRI
(5) Patients who are able to visit the hospital one year later
(6) Provision of written informed consent
Key exclusion criteria
(1) Patients who have a plan to stop antithrombotic agent
(2) Patients who have a plan to implant medical device not permitted at MRI examination.
(3) Patients who cannot take MRI one year later
(4) Patients that the doctor in charge judge not to be appropriate for participation in this study
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asako Nakamura |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Cerebrovascular Medicine and Neurology
Zip code
Address
1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
asakoro1012@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asako Nakamura |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Cerebrovascular Medicine and Neurology
Zip code
Address
1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
Homepage URL
asakoro1012@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
Address
Tel
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
| 2017 | Year | 12 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2017 | Year | 12 | Month | 10 | Day |
Last modified on
| 2018 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034452
