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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040720
Receipt No. R000046484
Scientific Title Assessment of the 10-year risk of coronary heart disease using the Suita score in stroke patients and association with stroke recurrence
Date of disclosure of the study information 2020/06/11
Last modified on 2020/06/11

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Basic information
Public title An observational study that assesses the risk of developing coronary heart disease in stroke patients and investigates the prognosis.
Acronym Risk assessment of developing coronary heart disease in stroke patients and prognosis
Scientific Title Assessment of the 10-year risk of coronary heart disease using the Suita score in stroke patients and association with stroke recurrence
Scientific Title:Acronym Assessment of the 10-year risk of coronary heart disease in stroke patients and association with stroke recurrence
Region
Japan

Condition
Condition stroke
Classification by specialty
Cardiology Neurology Neurosurgery
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of 10-years risk of developing coronary heart disease in stroke patients using the Suita score. Observation of the association between risk of developing coronary heart disease and recurrence of stroke.
Basic objectives2 Others
Basic objectives -Others Association of risk of developing coronary heart disease in patients with stroke and stroke recurrence
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Assessment risk of developing coronary heart disease in patients with ischemic stroke
Key secondary outcomes Association of risk of developing coronary heart disease in patients with stroke and stroke recurrence

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 Patients diagnosed and hospitalized for stroke
Key exclusion criteria None
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Miyamoto
Middle name
Last name Yoshinori
Organization Brain Attack Center Ota Memorial Hospital
Division name Division of Cardiology
Zip code 720-0825
Address 3-6-28 Okinogami, Fukuyama City, Hiroshima prefecture, Japan
TEL 0849318650
Email miyamox0707@gmail.com

Public contact
Name of contact person
1st name Miyamoto
Middle name
Last name Yoshinori
Organization Brain Attack Center Ota Memorial Hospital
Division name Division of Cardiology
Zip code 720-0825
Address 3-6-28 Okinogami, Fukuyama City, Hiroshima prefecture, Japan
TEL 0849318650
Homepage URL
Email miyamox0707@gmail.com

Sponsor
Institute Division of Cardiology, Brain Attack Center Ota Memorial Hospital
Institute
Department

Funding Source
Organization Brain Attack Center Ota Memorial Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Department of Ota cerebrovascular research institution
Address 3-6-28 Okinogami, Fukuyama City, Hiroshima prefecture, Japan
Tel 0849318650
Email fukusima@shouwa.or.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 脳神経センター大田記念病院

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 11 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2020 Year 06 Month 01 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2023 Year 12 Month 31 Day

Other
Other related information Assessment of risk of coronary artery disease in patients with stroke and its association with stroke recurrence
Assessment of risk of atherosclerotic cardiovascular disease risk in stroke patients
Identification of stroke recurrence predictors
Evaluation of lifestyle habits of stroke patients

Management information
Registered date
2020 Year 06 Month 11 Day
Last modified on
2020 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046484

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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