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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020636
Receipt No. R000023816
Scientific Title Risk stratification of cardiogenic cerebral embolism using serological parameters, and efficacy and safety of pharmacological and non-pharmacological treatment: prospective study
Date of disclosure of the study information 2016/01/19
Last modified on 2016/02/13

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Basic information
Public title Risk stratification of cardiogenic cerebral embolism using serological parameters, and efficacy and safety of pharmacological and non-pharmacological treatment: prospective study
Acronym Prospective study of risk stratification of cardiogenic cerebral embolism using serological parameters
Scientific Title Risk stratification of cardiogenic cerebral embolism using serological parameters, and efficacy and safety of pharmacological and non-pharmacological treatment: prospective study
Scientific Title:Acronym Prospective study of risk stratification of cardiogenic cerebral embolism using serological parameters
Region
Japan

Condition
Condition Atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To stratify risk of cardiogenic cerebral embolism using serological parameters
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes death, cerebral infarction, bleeding complication
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 Patients with atrial fibrillation
Key exclusion criteria (1) patients who could not receive anticoagulation
(2) patients with severely impaired renal function
(3) patients with absolute indication for warfarin
(4) patients who are considered as ineligible for this study by attending physician
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kengo Kusano
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565 Japan
TEL 06-6833-5012
Email kusanokengo@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Koji Miyamoto
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565 Japan
TEL 06-6833-5012
Homepage URL
Email kojimiya@hsp.ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Department of Cardiovascular Medicine
Division of Arrhythmia and Electrophysiology
Institute
Department

Funding Source
Organization Intramural Research Fund for Cardiovascular Diseases of National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 01 Month 19 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
2014 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study ongoing
Case control study
Patients with atrial fibrillation who visit our hospital from Aug 2014
End point:survival rate, cause of death, thromboembolic event, hemorrhage complication

Management information
Registered date
2016 Year 01 Month 19 Day
Last modified on
2016 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023816

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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