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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044669
Receipt No. R000051012
Scientific Title To evaluate that catheter ablation of atrial fibrillation decrease serum uric acid level
Date of disclosure of the study information 2021/06/28
Last modified on 2021/06/26

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Basic information
Public title To evaluate that catheter ablation of atrial fibrillation decrease serum uric acid level
Acronym Study of association between AF ablation and uric acid level
Scientific Title To evaluate that catheter ablation of atrial fibrillation decrease serum uric acid level
Scientific Title:Acronym Study of association between AF ablation and uric acid level
Region
Japan

Condition
Condition Atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective was to explore that the catheter ablation for AF patients effects uric acid (UA), sugar and lipid metabolism and to reveal the association among these laboratory parameters.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biomarkers of uric acid (UA), sugar and lipid metabolism after catheter ablation
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 AF patients who underwent initial AF ablation in our hospital between was included.
Key exclusion criteria Patients with exchanging oral medicines for heart failure, hypertension, diabetes mellitus, dyslipidemia, and hyperuricemia drug during follow-up period, and those with receiving dialysis were excluded.
Target sample size 210

Research contact person
Name of lead principal investigator
1st name Daisetsu
Middle name
Last name Aoyama
Organization University of Fukui
Division name Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code 910-1193
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL 0776618800
Email daisetsu@u-fukui.ac.jp

Public contact
Name of contact person
1st name Daisetsu
Middle name
Last name Aoyama
Organization University of Fukui
Division name Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code 910-1193
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL 0776618800
Homepage URL
Email daisetsu@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization No conflicts
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 University of Fukui
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
Tel 0776618800
Email daisetsu@u-fukui.ac.jp

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
2021 Year 06 Month 28 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 Enrolling by invitation
Date of protocol fixation
2021 Year 06 Month 26 Day
Date of IRB
2021 Year 05 Month 12 Day
Anticipated trial start date
2021 Year 06 Month 28 Day
Last follow-up date
2021 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study was a single-center, retrospective cohort analysis and AF patients who underwent initial AF ablation in our hospital between January 2011 and April 2021 was included.

Management information
Registered date
2021 Year 06 Month 26 Day
Last modified on
2021 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051012

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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