UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010662 |
|---|---|
| Receipt number | R000012310 |
| Scientific Title | The effect of right ventricular pacing on vascular endothelial function in SSS or AVB patients |
| Date of disclosure of the study information | 2013/05/08 |
| Last modified on | 2013/10/01 13:38:21 |
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Basic information
Public title
The effect of right ventricular pacing on vascular endothelial function in SSS or AVB patients
Acronym
The effect of right ventricular pacing on vascular endothelial function
Scientific Title
The effect of right ventricular pacing on vascular endothelial function in SSS or AVB patients
Scientific Title:Acronym
The effect of right ventricular pacing on vascular endothelial function
Region
| Japan |
Condition
Condition
Sick sinus syndrome,
Advanced atrioventricular block
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the effects of right ventricular pacing on vascular endothelial function in subjects with pacemakers.
Basic objectives2
Others
Basic objectives -Others
To research the relations between vascular endothelial function and premature ventricular contraction or some laboratory data in subjects with pacemakers.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of vascular endothelial function
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients previously implanted with a pacemaker for sick sinus syndrome or advanced atrioventricular block and underwent pacemaker check at our hospital.
Key exclusion criteria
Patients considered as inappropriate to participate in this study by attending physicians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichitaro Abe |
Organization
Nankai hospital
Division name
Cardiovascular department
Zip code
Address
11-20 Tokiwanishimachi, Saiki, Oita, Japan
TEL
0972-22-0547(ext.722)
i-taro@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichitaro Abe |
Organization
Nankai hospital
Division name
Cardiovascular department
Zip code
Address
11-20 Tokiwanishimachi, Saiki, Oita, Japan
TEL
0972-22-0547
Homepage URL
shomu@nankai-hp.jp
Sponsor or person
Institute
Nankai hospital
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
| 2013 | Year | 05 | Month | 08 | 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
Our observations suggest that frequency of right ventricular pacing is associated with endothelial dysfunction.
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
| 2013 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 08 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 30 | Day |
Other
Other related information
We evaluate the relationship between vascular endothelial function, premature ventricular contraction and some laboratory data in subjects with pacemakers.
Management information
Registered date
| 2013 | Year | 05 | Month | 08 | Day |
Last modified on
| 2013 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012310
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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