UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025073 |
|---|---|
| Receipt number | R000028841 |
| Scientific Title | Verification and improvement of detection accuracy for atrial fibrillation from IHB (Irregular heart beat) measured by home blood pressure monitoring |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2019/01/04 15:56:57 |
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Basic information
Public title
Verification and improvement of detection accuracy for atrial fibrillation from IHB (Irregular heart beat) measured by home blood pressure monitoring
Acronym
Verification and improvement of detection accuracy for atrial fibrillation from IHB (Irregular heart beat) measured by home blood pressure monitoring (%IHB)
Scientific Title
Verification and improvement of detection accuracy for atrial fibrillation from IHB (Irregular heart beat) measured by home blood pressure monitoring
Scientific Title:Acronym
Verification and improvement of detection accuracy for atrial fibrillation from IHB (Irregular heart beat) measured by home blood pressure monitoring (%IHB)
Region
| Japan |
Condition
Condition
Chronic atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore early detecting methods for atrial fibrillation which is a high risk factor for cardiovascular events by using home blood pressure monitoring
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection accuracy of atrial fibrillation from IHB (Irregular heart beat) measured by home blood pressure monitoring
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
-Patients with chronic atrial fibrillation
-Age >=20 years old
Key exclusion criteria
Considered not eligible for the study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuomi Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of cardiovascular Medicine, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi Japan 329-0498
TEL
0285-58-7344
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuomi Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of cardiovascular Medicine, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi Japan 329-0498
TEL
0285-58-7344
Homepage URL
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University School of Medicine
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
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 | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study validate the IHB detection accuracy of the home blood pressure monitoring by comparing electrocardiogram
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028841
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
