UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009022 |
|---|---|
| Receipt number | R000010585 |
| Scientific Title | The relationship of anti-nuclear antibody and cardiac function in patients with right ventricular pacing |
| Date of disclosure of the study information | 2012/10/02 |
| Last modified on | 2012/10/02 10:47:15 |
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Basic information
Public title
The relationship of anti-nuclear antibody and cardiac function in patients with right ventricular pacing
Acronym
The relationship of anti-nuclear antibody and cardiac function in patients with right ventricular pacing
Scientific Title
The relationship of anti-nuclear antibody and cardiac function in patients with right ventricular pacing
Scientific Title:Acronym
The relationship of anti-nuclear antibody and cardiac function in patients with right ventricular pacing
Region
| Japan |
Condition
Condition
Patients who have been implanted pacemaker or ICD
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Right ventricular (RV) pacing is associated with increased risk of heart failure (HF) in adults with structural heart disease (SHD). It is unclear whether this propensity for deterioration in cardiac function results exclusively from pacing-induced ventricular dyssynchrony or from the interaction of pacing with an abnormal substrate. Immune-mediated cardiomyopathy has been recognized in patients with a positive rheumatoid factor test result and in infants born to mothers with antinuclear antibodies (ANA). In the U.S., it has been reported that ANA positive patients with congenital complete atrioventricular block after pacemaker implantation decrease cardiac function. However, the relationship between the presence of ANA and cardiac function in patients with right ventricular pacing in the Japanese population has not been studied. In this clinical trial, with the aim of verifying the relationship between the presence of ANA and cardiac function in patients with right ventricular pacing in Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ANA and left ventricular ejection fraction
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 right ventricular pacing lead who were implanted pacemaker or ICD, and followed at Yokohama city university hospital.
Key exclusion criteria
Patients who do not consent to this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Ishikawa |
Organization
Yokohama city university hospital
Division name
CCU
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa-ken, Japan
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Kimura |
Organization
Yokohama city university hospital
Division name
CCU
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa-ken, Japan
TEL
Homepage URL
Sponsor or person
Institute
Yokohama city university hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
YES
Study ID_1
B120510012
Org. issuing International ID_1
Yokohama city university hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2012 | Year | 10 | Month | 02 | Day |
Last modified on
| 2012 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010585
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