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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000023007
Receipt No. 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 2020/07/07

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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
Middle name
Last name Yasuyuki Taki
Organization Tohoku University, Institute of Development, Aging and cancer
Division name Nuclear Medicine and Radiology
Zip code
Address 4-1, Seiryo, Aoba, Sendai, Miyagi, Japan
TEL 022-717-8556
Email ytaki@idac.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Tatewaki
Organization Tohoku University, Institute of Development, Aging and cancer
Division name Nuclear Medicine and Radiology
Zip code
Address 4-1, Seiryo, Aoba, Sendai, Miyagi, Japan
TEL 022-717-8559
Homepage URL
Email yasuko.tatewaki.a7@tohoku.ac.jp

Sponsor
Institute Tohoku University, Institute of Development, Aging and cancer
Institute
Department

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
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
2016 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Suspended
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
2020 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026521

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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