UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037847 |
|---|---|
| Receipt number | R000043153 |
| Scientific Title | blood glucose transition using glucose monitoring system for atrial fibrillation patients undergoing catheter ablation |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/08/29 15:27:40 |
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Basic information
Public title
blood glucose transition using glucose monitoring system for atrial fibrillation patients undergoing catheter ablation
Acronym
blood glucose transition of atrial fibrillation patients
Scientific Title
blood glucose transition using glucose monitoring system for atrial fibrillation patients undergoing catheter ablation
Scientific Title:Acronym
blood glucose transition of atrial fibrillation patients undergoing catheter ablation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will clarify the mechanism of post-procedure hemodynamics and metabolic improvement by catheter ablation, and whether therapeutic effects can be expected for complicated diseases such as hypertension and diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of catheter ablation effect on blood glucose transition for atrial fibrillation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
A continuous blood glucose recording test using a glucose monitoring system is performed pre and post procedure.
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 who undergo catheter ablation for atrial fibrillation in our hospital, and who have obtained consent for this study
Key exclusion criteria
Patients with dialysis, pregnancy and other implantable medical devices such as pacemakers
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tada |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Cardiovascular Medicine
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8800
daisetsu@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Daisetsu |
| Middle name | |
| Last name | Aoyama |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Cardiovascular Medicine
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8800
Homepage URL
daisetsu@u-fukui.ac.jp
Sponsor or person
Institute
Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medical Sciences, University of Fukui
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
Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel
0776-61-8800
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
| 2019 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 29 | Day |
Last modified on
| 2019 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043153
