UMIN-CTR Clinical Trial

Public title

Longitudinal study for Cognitive function and Brain structural changes associated with Ablation-therapy for Atrial fibrillation

Acronym

Longitudinal study for Cognitive function and Brain structural changes associated with Ablation-therapy for Atrial fibrillation

Scientific Title

Longitudinal study for Cognitive function and Brain structural changes associated with Ablation-therapy for Atrial fibrillation

Scientific Title:Acronym

Longitudinal study for Cognitive function and Brain structural changes associated with Ablation-therapy for Atrial fibrillation

Region

Japan

Condition

Atrial fibrillation

Classification by specialty

Cardiology	Neurology	Radiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to investigate a possible influence of Ablation therapy for patients with atrial fibrillation on cognitive function and brain structure and function using cognitive-psychological tests and brain magnetic resonance imaging (MRI)

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

(1) Cognitive function, (2)Gray matter volume, (3)Cerebral blood flow (CBF)
Comparison those parameters between before and after 6 months following Ablation therapy.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients with paroxysmal or persistent atrial fibrillation in whom a clinical decision was made to perform ablation therapy.
Patients with a written informed consent.

Key exclusion criteria

(1)patients with past history of neuro-psychological disorders and significant organic diseases
(2)Patients with hemorrhagic symptoms
(3)Patients with coagulation defect associated with hepatic disease
(4)Patients with renal failure
(5)Patients with difficulty in obtaining written informed consent
(6)Patients in whom physician-in-charge decides unsuitable for this study
(7)Patients with difficulty in evaluating brain MRI:Patients undergoing Pacemaker-implantation, coronary artery stenting and other metal device implantation or patients with claustrophobia
(8)Patients with pregnancy

Target sample size

100

Name of lead principal investigator

1st name	Yasuyuki
Middle name
Last name	Taki

Organization

Tohoku University, Institute of Development, Aging and cancer

Division name

Aging Research and Geriatric Medicine

Zip code

980-8575

Address

4-1, Seiryo, Aoba, Sendai, Miyagi, Japan

TEL

0227178559

Email

ytaki@idac.tohoku.ac.jp

Name of contact person

1st name	Yasuko
Middle name
Last name	Tatewaki

Organization

Tohoku University, Institute of Development, Aging and cancer

Division name

Aging Research and Geriatric Medicine

Zip code

980-8575

Address

4-1, Seiryo, Aoba, Sendai, Miyagi, Japan

TEL

022-717-8559

Homepage URL

Email

yasuko.tatewaki.a7@tohoku.ac.jp

Institute

Tohoku University, Institute of Development, Aging and cancer

Institute

Department

Personal name

Organization

Tohoku University, Institute of Development, Aging and cancer

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tohoku University

Address

1-1, Seiryo, Aoba, Sendai, Miyagi, Japan

Tel

022-717-8007

Email

med-kenkyu@grp.tohoku.ac.jp

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

2016

Year

07

Month

10

Day

URL releasing protocol

https://www.mdpi.com/2077-0383/11/15/4346

Publication of results

Published

URL related to results and publications

https://www.mdpi.com/2077-0383/11/15/4346

Number of participants that the trial has enrolled

8

Results

Cognitive-psychological function was improved, and rCBF was significantly increased in the left posterior cingulate cortex (PCC) (p=0.013), whereas decreased cortical thickness was found in the left posterior insular cortex (p =0.023).

Results date posted

2023

Year

07

Month

10

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This study enrolled eight right-handed patients with persistent AF who visited the division of Cardiology, Sendai City Hospital between 1 February 2016 and 31 July 2019. Eligible patients were those with persistent AF for whom a clinical decision was made to perform ablation therapy. The exclusion criteria for all patients were: neuro-psychological disorders, coexisting severe medical conditions or terminal diseases (e.g., stroke, Parkinson disease, thyroid/parathyroid disease, and cancer) that may influence the results of the imaging and cognitive studies, difficulty in obtaining written informed consent, difficulty in undergoing brain MRI (pacemaker-implantation, coronary artery stenting, other metal device implantation, or claustrophobia), difficulty in undergoing cognitive tests (amblyopia, deafness, orthopedic impairment), and failure to acquire rhythm control through ablation therapy.

Participant flow

All data and information regarding the clinical courses were collected and reviewed from medical records maintained by Sendai City Hospital. Before and 6 months after the latest ablation therapy by which rhythm control was acquired, cognitive-psychological tests, cardiac function with echocardiography, serum BNP concentrations, regional cerebral blood flow with ASL MRI, and regional cortical thickness with structural MRI were measured. The control group included seven subjects of similar age who had no arrhythmia and no organic or psychological disorders. They underwent cognitive psychological tests and MRI images for comparisons with the AF group.

Adverse events

N/A

Outcome measures

rCBF, regional cortical thickness

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2016

Year

06

Month

27

Day

Date of IRB

2016

Year

06

Month

28

Day

Anticipated trial start date

2016

Year

08

Month

01

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is an observational study. The participants of this study include 100 patients with atrial fibrillation who plan to undergo ablation therapy with written-informed consent.
Participants will undergo cognitive tests and brain MRI at two-time points, before and after 6 months following ablation therapy.

Registered date

2016

Year

07

Month

04

Day

Last modified on

2023

Year

07

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026521