UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008183 |
|---|---|
| Receipt number | R000009642 |
| Scientific Title | Time-course changes in biochemical markers of inflammation and collagen turnover and echocardiographic parameters after catheter ablation of atrial fibrillation |
| Date of disclosure of the study information | 2012/09/30 |
| Last modified on | 2017/06/20 10:13:58 |
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Basic information
Public title
Time-course changes in biochemical markers of inflammation and collagen turnover and echocardiographic parameters after catheter ablation of atrial fibrillation
Acronym
Time-course changes in biochemical markers and echocardiographic parameters after AF ablation
Scientific Title
Time-course changes in biochemical markers of inflammation and collagen turnover and echocardiographic parameters after catheter ablation of atrial fibrillation
Scientific Title:Acronym
Time-course changes in biochemical markers and echocardiographic parameters after AF ablation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the time-course changes of atrial function and inflammation and fibrosis in terms of echocardiographic parameters and biochemical markers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of atrial fibrillation
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients underwent catheter ablation of atrial fibrillation
Key exclusion criteria
thrombus in the cardiac chamber
history of stroke within recent 6 months
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Okumura |
Organization
Nihon University School of Medicine
Division name
Cardiology
Zip code
Address
30-1 Ohyaguchi, Kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
yasuwo128@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Okumura |
Organization
Nihon University School of Medicine
Division name
Cardiology
Zip code
Address
30-1 Ohyaguchi, Kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
yasuwo128@yahoo.co.jp
Sponsor or person
Institute
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
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 | 09 | Month | 30 | 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
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
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Although LA volume gradually decreased during the follow-up periods, inflammatory markers decreased at 3mo-post-ablation but increased at 6mo-post-ablation, while collagen turnover biomarkers increased without recovery to baseline values at 3mo- and 6mo-post-ablation
Management information
Registered date
| 2012 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009642
