UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043612 |
|---|---|
| Receipt number | R000049795 |
| Scientific Title | Cognitive status after pacemaker implantation for bradycardia |
| Date of disclosure of the study information | 2021/03/15 |
| Last modified on | 2021/03/14 12:42:58 |
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Basic information
Public title
Cognitive status after pacemaker implantation for bradycardia
Acronym
Cognitive status after pacemaker implantation
Scientific Title
Cognitive status after pacemaker implantation for bradycardia
Scientific Title:Acronym
Cognitive status after pacemaker implantation
Region
| Japan |
Condition
Condition
Bradycardia
Classification by specialty
| Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate cognitive status after pacemaker implantation for elderly patients with cognitive decline
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive status and cerebral blood flow improvement after pacemaker implantation
Key secondary outcomes
Cardiac function
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Permanent pacing indication class 1, 2a for bradycardia or conduction system disturbance, MMSE equal or less than 23, MMSE equal or less than 27 plus MOCA-J equal or less than 25
Key exclusion criteria
age of less than 65 years old
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Togashi |
Organization
Kyorin University School of Medicine
Division name
Division of Advanced Arrhythmia Management
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL
0422-47-5511
toga@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Ikuko |
| Middle name | |
| Last name | Togashi |
Organization
Kyorin University School of Medicine
Division name
Division of Advanced Arrhythmia Management
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL
0422-47-5511
Homepage URL
toga@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyorin University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
Tel
0422-47-5513
ec@ks.kyorin-u.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
| 2021 | Year | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center observation study
Management information
Registered date
| 2021 | Year | 03 | Month | 14 | Day |
Last modified on
| 2021 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049795
