UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2014 Year 07 Month 30 Day
Date of IRB	2020 Year 02 Month 14 Day
Anticipated trial start date	2014 Year 07 Month 30 Day
Last follow-up date	2020 Year 02 Month 12 Day
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	2022 Year 01 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023816