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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000189
Receipt No. R000000263
Scientific Title Japan Thrombosis Registry for Atrial fibrillation, Coronary (Myocardial Infarction) or Cerebrovascular (Cerebral Infarction / Cerebral hemorrhage) Events
Date of disclosure of the study information 2005/10/01
Last modified on 2014/04/12

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Basic information
Public title Japan Thrombosis Registry for Atrial fibrillation, Coronary (Myocardial Infarction) or Cerebrovascular (Cerebral Infarction / Cerebral hemorrhage) Events
Acronym Japan Thrombosis Registry for Atrial fibrillation, or Cerebrovascular Events (J-TRACE)
Scientific Title Japan Thrombosis Registry for Atrial fibrillation, Coronary (Myocardial Infarction) or Cerebrovascular (Cerebral Infarction / Cerebral hemorrhage) Events
Scientific Title:Acronym Japan Thrombosis Registry for Atrial fibrillation, or Cerebrovascular Events (J-TRACE)
Region
Japan

Condition
Condition stroke, myocardial infarction, atrial fibrillation
Classification by specialty
Medicine in general Cardiology Neurology
Surgery in general Vascular surgery Emergency medicine
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recurrence rate of Coronary or Cerebrovascular Events
Basic objectives2 Others
Basic objectives -Others Recurrence rate of Coronary or Cerebrovascular Events
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Recurrence rate of Coronary or Cerebrovascular Events
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
90 years-old >
Gender Male and Female
Key inclusion criteria stroke , myocardial infarction, atrial fibrillation
Key exclusion criteria In-patient due to acute phase target disease(s)
Target sample size 15000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Ikeda
Organization Department of Medicine, Keio University School of Medicine
Division name Department of Medicine
Zip code
Address 35 Shinanomachi, Shinjuku, tokyo, japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Goto
Organization Department of Medicine, Tokai University School of Medicine
Division name Department of Medicine
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan
TEL 0463-93-1121
Homepage URL http://www.j-trace.com
Email shinichi@is.icc.u-tokai.ac.jp

Sponsor
Institute Society for the J-TRACE
Institute
Department

Funding Source
Organization The Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

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
2005 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
CV even rate in stable outpatients recruited in the J-TRACE registry was 3.53 events per 100 person-years (95% confidence interval [CI]: 3.11-3.99).
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 Completed
Date of protocol fixation
2004 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2005 Year 01 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
2008 Year 06 Month 01 Day
Date trial data considered complete
2008 Year 06 Month 01 Day
Date analysis concluded
2008 Year 06 Month 01 Day

Other
Other related information J-Trace is the observation study to clarify the incidence of atherothrombosis and thrombotic disease caused by atrial fibrillation.

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2014 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000263

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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