UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023007 |
|---|---|
| Receipt number | R000026521 |
| Scientific Title | Longitudinal study for Cognitive function and Brain structural changes associated with Ablation-therapy for Atrial fibrillation |
| Date of disclosure of the study information | 2016/07/10 |
| Last modified on | 2023/07/10 10:17:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
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
Condition
Atrial fibrillation
Classification by specialty
| Cardiology | Neurology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
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
| 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
Research contact person
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
ytaki@idac.tohoku.ac.jp
Public contact
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
yasuko.tatewaki.a7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University, Institute of Development, Aging and cancer
Institute
Department
Personal name
Funding Source
Organization
Tohoku University, Institute of Development, Aging and cancer
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
Tohoku University
Address
1-1, Seiryo, Aoba, Sendai, Miyagi, Japan
Tel
022-717-8007
med-kenkyu@grp.tohoku.ac.jp
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
| 2016 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2077-0383/11/15/4346
Publication of results
Published
Result
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
Progress
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
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.
Management information
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
