UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012606 |
|---|---|
| Receipt number | R000014600 |
| Scientific Title | Effect of epicardial adipose tissue in atrial fibrillation |
| Date of disclosure of the study information | 2013/12/17 |
| Last modified on | 2019/03/05 00:45:53 |
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Basic information
Public title
Effect of epicardial adipose tissue in atrial fibrillation
Acronym
AF and epicardial adipose tissue
Scientific Title
Effect of epicardial adipose tissue in atrial fibrillation
Scientific Title:Acronym
AF and epicardial adipose tissue
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the epicardial adipose tissue by using a cardiac CT examination for patients with atrial fibrillation and to evaluate the relationship about the onset, the mechanism and pathology of atrial fibrillation.
Basic objectives2
Others
Basic objectives -Others
meaning of examination
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
recurrence of atrial fibrillation after catheter ablation therapy
Key secondary outcomes
1)distribution, accumulation and property of epicardial adipose tissue
2)blood examination
3)echocardiography
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
1)Diagnosed as atrial fibrillation by electrocardiogram
2)After catheter ablation therapy for atrial ablation
3)cardiac CT examination before the ablation
Key exclusion criteria
1)moderate or severe valvular disease
2)reduced cardiac function (left ventricular ejection fraction<55%)
3)severe obese cases (BMI>30kg/m2)
4)heart failure cases (BNP>200pg/ml)
5)history of open-heart surgery
6)inflammatory or infection disease cases
7)Patients rejected the use of clinical data
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Kanazawa University Hospital
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takaramachi, Kanazawa city, Ishikawa, Japan
TEL
076-265-2233
skaneko@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kusayama |
Organization
Kanazawa University Hospital
Division name
Department of Cardiology
Zip code
Address
13-1 Takaramachi, Kanazawa city, Ishikawa, Japan
TEL
090-2838-0612
Homepage URL
ojiichan519@gmail.com
Sponsor or person
Institute
Kanazawa University, Department of Disease Control and Homeostasis
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University, Department of Disease Control and Homeostasis
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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 17 | 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
The mean epicardial addipose tissue density using CT was significantly higher in the patients with paroxysmal atrial fibrillation than in control patients.
Published from Journal of Cardiology. 2016; 68: 406-411.
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
| 2013 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
We investigate the recurrence of atrial fibrillation after the catheter ablation, and evaluate the distribution,t and CT values of epicardial adipose tissue by cardiac CT.
Management information
Registered date
| 2013 | Year | 12 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014600
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
