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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012436
Receipt No. R000014552
Scientific Title Evaluation of cardiac sympathetic activity before and after radiofrequency catheter ablation in patients with atrial fibrillation.
Date of disclosure of the study information 2013/11/29
Last modified on 2018/12/22

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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


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