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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039998
Receipt No. 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 2020/03/31

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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
Email 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
Email murakami.chisato.nt@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Asahikawa Medical Center
Institute
Department

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
Email 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 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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 23 Day
Date of IRB
2020 Year 03 Month 31 Day
Anticipated trial start date
2020 Year 04 Month 10 Day
Last follow-up date
2026 Year 03 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
2020 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045607

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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