UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020636 |
|---|---|
| Receipt number | 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 | 2022/01/24 07:48:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kojimiya@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Department of Cardiovascular Medicine
Division of Arrhythmia and Electrophysiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023816
