UMIN-CTR Clinical Trial

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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