UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014835 |
|---|---|
| Receipt number | R000017242 |
| Scientific Title | Research on heart rate variability evaluation of exercise testing during paroxysmal atrial fibrillation patients |
| Date of disclosure of the study information | 2014/08/11 |
| Last modified on | 2016/03/30 01:00:22 |
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Basic information
Public title
Research on heart rate variability evaluation of exercise testing during paroxysmal atrial fibrillation patients
Acronym
Research on heart rate variability evaluation of exercise testing during paroxysmal atrial fibrillation patients
Scientific Title
Research on heart rate variability evaluation of exercise testing during paroxysmal atrial fibrillation patients
Scientific Title:Acronym
Research on heart rate variability evaluation of exercise testing during paroxysmal atrial fibrillation patients
Region
| Japan |
Condition
Condition
paroxysmal atrial fibrillation
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if the heart rate variability during exercise is possible to predict atrial fibrillation induced by exercise in paroxysmal atrial fibrillation patients.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in heart rate variability during exercise
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
paroxysmal atrial fibrillation patients diagnosed by Holter ECG or ECG
Key exclusion criteria
patients who deny participating in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mori Nobuyoshi |
Organization
Tohoku University Graduate school of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai city, Miyagi
TEL
022-717-7353
n-mori@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mori Nobuyoshi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai city, Miyagi
TEL
022-717-7353
Homepage URL
n-mori@umin.net
Sponsor or person
Institute
Department of Internal Medicine and Rehabilitation Science, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 08 | Month | 11 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-sectional method
Management information
Registered date
| 2014 | Year | 08 | Month | 11 | Day |
Last modified on
| 2016 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017242
