UMIN-CTR Clinical Trial

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

Atrial fibrillation

Classification by specialty

Cardiology	Radiology	Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Cardiology, Hokkaido University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

11

Month

29

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2013

Year

11

Month

28

Day

Last modified on

2018

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014552