UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039998 |
|---|---|
| Receipt number | R000045607 |
| Scientific Title | A prospective study of the frequency of ischemic stroke and the prediction with CHADS2 score in patients with myotonic dystrophy. |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2024/03/04 07:35:36 |
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Basic information
Public title
A prospective study of the frequency of ischemic stroke and the prediction with CHADS2 score in patients with myotonic dystrophy.
Acronym
A prospective study of the frequency of ischemic stroke and the prediction with CHADS2 score in patients with myotonic dystrophy.
Scientific Title
A prospective study of the frequency of ischemic stroke and the prediction with CHADS2 score in patients with myotonic dystrophy.
Scientific Title:Acronym
A prospective study of the frequency of ischemic stroke and the prediction with CHADS2 score in patients with myotonic dystrophy.
Region
| Japan |
Condition
Condition
Myotonic dystrophy type 1
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the frequency of cerebral infarction in patients with myotonic dystrophy type 1 and the usefulness of CHADS2 score for predicting onset.
Basic objectives2
Others
Basic objectives -Others
We evaluate the usefulness of cerebral infarction frequency and CHADS2 score in patients with myotonic dystrophy type 1 (DM1). No coagulation abnormalities have been reported in DM1 patients. If atrial fibrillation becomes a risk factor for the development of cerebral infarction and the usefulness of the CHADS2 score becomes apparent, it is expected that anticoagulation therapy can prevent the onset of cerebral infarction in the general population.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
all ischemic strokes
Key secondary outcomes
atrial fibrillation, CHADS2 score, all deaths, Antithrombotic therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Central nervous system images are taken at the time of registration and at the end of observation.
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
Patients genetically diagnosed with myotonic dystrophy type 1
Key exclusion criteria
When the principal investigator or the research coordinator judges that participation in this research is inappropriate.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Yoshida |
Organization
National Hospital Organization Asahikawa Medical Center
Division name
Neurology
Zip code
0708644
Address
4048, 7chome, Hanasakicho, Asahikawa, Hokkaido
TEL
0166-51-3161
yoshida.kosuke.rv@hosp.mail.go.jp
Public contact
Name of contact person
| 1st name | Murakami |
| Middle name | |
| Last name | Chisato |
Organization
National Hospital Organization Asahikawa Medical Center
Division name
Clinical Research Department
Zip code
0708644
Address
4048, 7chome, Hanasakicho, Asahikawa, Hokkaido
TEL
0166-51-3161
Homepage URL
murakami.chisato.nt@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Asahikawa Medical Center
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
National Hospital Organization Asahikawa Medical Center Institutional Review Board
Address
4048, 7chome, Hanasakicho, Asahikawa, Hokkaido
Tel
0166-51-3161
murakami.chisato.nt@mail.hosp.go.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
| 2020 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
65
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
| 2020 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045607
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
