UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of epicardial adipose tissue in atrial fibrillation
Title of the study (Brief title)	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	Shuichi Kaneko
Organization	Kanazawa University Hospital
Division name	Department of Disease Control and Homeostasis
Address	13-1 Takaramachi, Kanazawa city, Ishikawa, Japan
TEL	076-265-2233
Email	skaneko@m-kanazawa.jp

Public contact
Name of contact person	Takashi Kusayama
Organization	Kanazawa University Hospital
Division name	Department of Cardiology
Address	13-1 Takaramachi, Kanazawa city, Ishikawa, Japan
TEL	090-2838-0612
Homepage URL
Email	ojiichan519@gmail.com

Sponsor
Institute	Kanazawa University, Department of Disease Control and Homeostasis
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014600