UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028472 |
|---|---|
| Receipt number | R000032592 |
| Scientific Title | An observational study to evaluate risk factors for atrial fibrillation recurrence after the first session of catheter ablation. |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2022/08/04 10:10:52 |
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Basic information
Public title
An observational study to evaluate risk factors for atrial fibrillation recurrence after the first session of catheter ablation.
Acronym
An observational study to evaluate risk factors for atrial fibrillation reccurence after catheter ablation.
Scientific Title
An observational study to evaluate risk factors for atrial fibrillation recurrence after the first session of catheter ablation.
Scientific Title:Acronym
An observational study to evaluate risk factors for atrial fibrillation reccurence after catheter ablation.
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate risk factors for atrial fibrillation recurrence.
Basic objectives2
Others
Basic objectives -Others
To evaluate risk factors for atrial fibrillation recurrence.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence 3 month after procedure
Key secondary outcomes
Recurrence after procedure
Proteomics, Metabolomics
Left atrial structure and function assessed by standard 2D, 3D and speckle traking echocardiography,and cardiac MRI
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 after first pulmonary vein isolation for atrial fibrillation.
Age 20 years or over.
Key exclusion criteria
Significant cardiac structure disease.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Shimokawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
+81227177153
nochioka@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Nochioka |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
+81227177153
Homepage URL
nochioka@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
The Japan Agency for Medical Research and Development.
Institute
Department
Personal name
Funding Source
Organization
The Japan Agency for Medical Research and Development.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 01 | Day |
Other
Other related information
Physical examination, blood sampling, Holetr ECG,12 lead ECG,Echocardiography
Management information
Registered date
| 2017 | Year | 07 | Month | 31 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032592
