UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of cardiac sympathetic activity before and after radiofrequency catheter ablation in patients with atrial fibrillation.
Acronym	Evaluation of cardiac sympathetic activity in patients with atrial fibrillation.
Scientific Title	Evaluation of cardiac sympathetic activity before and after radiofrequency catheter ablation in patients with atrial fibrillation.
Scientific Title:Acronym	Evaluation of cardiac sympathetic activity in patients with atrial fibrillation.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy of radiofrequency catheter ablation to cardiac sympathetic activity in the patients with atrial fibrillation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Compare cardiac sympathetic activity in normal volunteer and patients with atrial fibrillation. Compare cardiac sympathetic activity before and after radiofrequency catheter ablation in the patients with atrial fibrillation.
Key secondary outcomes	1) Evaluate the relationship of recurrence of atrial fibrillation and cardiac sympathetic activity in the patients with atrial fibrillation after radiofrequency catheter ablation. 2) Evaluate the relationship of atrial or ventricular fibrosis and cardiac sympathetic activity.

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	Medicine
Interventions/Control_1	Normal volunteer: C-11 hydroxyephedrine (dosage: 185 MBq, only once) Patients with atrial fibrillation: C-11 hydroxyephedrine (dosage: 185 MBq, before and after the therapy)
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	1. Patients with atrial fibrillation We enrolled the outpatients of the cardiovascular department of Hokkaido University Hospital who satisfy below criteria, 1) who is 20 years or older 2) who is scheduled radiofrequency catheter ablation to atrial fibrillation 3) who is explained well about this study and consent to the study. 2. Normal volunteer We will collect the volunteer who satisfy below criteria. 1) age between 30 to 70 years old 2) who has not been diagnosed cardiac disease 3) who has no symptom such as chest pain 4) who is explained well about this study and consent to this study.
Key exclusion criteria	Exclusion criteria is described below 1) who use adrenergic neuron blocking drug regularly 2) claustrophobia 3) patients with atrial fibrillation due to mitral stenosis 4) ischemic heart disease 5) cardiomyopathy 6) chronic heart failure 7) diabetes mellitus 8) dementia 9) advanced chronic kidney disease (eGFR < 30 ml/min/1.73m^2) 10) mechanical device in their body such as pacemaker or clip for aneurysm 11) who can't consent to this study ( (3)-(5) is only adopted to the patients with atrial fibrillation)
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Tsutsui
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code
Address	N-15, W-7, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Email	htsutsui@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Atsuro Masuda
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Nuclear Medicine
Zip code
Address	N-15, W-7, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Homepage URL
Email	atsuromasuda@med.hokudai.ac.jp

Sponsor
Institute	Department of Cardiology, Hokkaido University Hospital
Institute
Department

Funding Source
Organization	None
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
Email

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	2013 Year 11 Month 29 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	Sympathetic nervous activity decreased in the patients with atrial fibrillation.
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	Terminated
Date of protocol fixation	2013 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date	2013 Year 11 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 28 Day
Last modified on	2018 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014552

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.