UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Time-course changes in biochemical markers of inflammation and collagen turnover and echocardiographic parameters after catheter ablation of atrial fibrillation
Title of the study (Brief title)	Time-course changes in biochemical markers and echocardiographic parameters after AF ablation
Region	Japan

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

Objectives
Narrative objectives1	To examine the time-course changes of atrial function and inflammation and fibrosis in terms of echocardiographic parameters and biochemical markers
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence of atrial fibrillation
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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients underwent catheter ablation of atrial fibrillation
Key exclusion criteria	thrombus in the cardiac chamber history of stroke within recent 6 months
Target sample size	60

Research contact person
Name of lead principal investigator	Yasuo Okumura
Organization	Nihon University School of Medicine
Division name	Cardiology
Address	30-1 Ohyaguchi, Kamicho, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	yasuwo128@yahoo.co.jp

Public contact
Name of contact person	Yasuo Okumura
Organization	Nihon University School of Medicine
Division name	Cardiology
Address	30-1 Ohyaguchi, Kamicho, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Homepage URL
Email	yasuwo128@yahoo.co.jp

Sponsor
Institute	Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Division of Cardiology, Department of Medicine, Nihon University School of Medicine
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

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 10 Month 01 Day
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Although LA volume gradually decreased during the follow-up periods, inflammatory markers decreased at 3mo-post-ablation but increased at 6mo-post-ablation, while collagen turnover biomarkers increased without recovery to baseline values at 3mo- and 6mo-post-ablation

Management information
Registered date	2012 Year 06 Month 16 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009642