UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009645 |
|---|---|
| Receipt number | R000011314 |
| Scientific Title | Change of coagulation system after cardiac implantable electronic device implantation |
| Date of disclosure of the study information | 2012/12/27 |
| Last modified on | 2012/12/27 10:42:10 |
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Basic information
Public title
Change of coagulation system after cardiac implantable electronic device implantation
Acronym
Change of coagulation system after cardiac implantable electronic device implantation
Scientific Title
Change of coagulation system after cardiac implantable electronic device implantation
Scientific Title:Acronym
Change of coagulation system after cardiac implantable electronic device implantation
Region
| Japan |
Condition
Condition
arrhythmia, heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether coagulation and fibrinolytic system excess after implantation of cardiac implantable electronic devices or not.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Value of coagulation and fibrinolytic systems before and after device implantation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implantation or exchange of pacemaker, implantable cardiac defibrillator, or cardiac resynchronization therapy devices.
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
1) Patients with bradycardia , tachyarrhythmia, or heart failure who need to implant cardiac implantable electronic devices.
2) Admitted patients
3) Patients with informed consent in paper
Key exclusion criteria
1) Needs to continue anticoagulation therapy
2) Judged inappropriated patients by Doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Takamura |
Organization
Kanazawa University
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Takamura |
Organization
Kanazawa University
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
Homepage URL
Sponsor or person
Institute
Disease Control and Homeostasis, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 12 | Month | 27 | 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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 27 | Day |
Last modified on
| 2012 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011314
