UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033266 |
|---|---|
| Receipt number | R000037928 |
| Scientific Title | The study for detecting the recurrence of atrial fibrillation by using home blood pressure monitoring device and investigating the related factors |
| Date of disclosure of the study information | 2018/07/05 |
| Last modified on | 2022/07/08 10:00:55 |
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Basic information
Public title
The study for detecting the recurrence of atrial fibrillation by using home blood pressure monitoring device and investigating the related factors
Acronym
The study for detecting the recurrence of atrial fibrillation
Scientific Title
The study for detecting the recurrence of atrial fibrillation by using home blood pressure monitoring device and investigating the related factors
Scientific Title:Acronym
The study for detecting the recurrence of atrial fibrillation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.To verify the effectiveness of detecting the recurrence of atrial fibrillation by using home blood pressure monitoring device
2.To investigate the relationship between the home BP status after catheter ablation and the recurrence of atrial fibrillation
3.To investigate the relationship between the home BP status before catheter ablation and electrophysiological findings
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of accuracy in AF Detection between the Holter electrocardiography and the home blood pressure monitoring device with irregular heart beat detection algorism
Key secondary outcomes
1.Relationship between the recurrence of atrial fibrillation and blood pressure levels or blood pressure variability
2.Relationship between the atrial arrhythmogenic substrate and blood pressure levels or blood pressure variability
3.Relationship between the recurrence of atrial fibrillation and each exam findings
4.For the recurrence cases, comparison between the first and second electrophysiological findings
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients are asked to measure home blood pressure in the morning and before going to bed for 18 months by using home blood pressure monitoring device with irregular heart beat detection algorism.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are scheduled catheter ablation for atrial fibrillation
(2) Male or female, age 20 to 84 years.
(3) Patients with written informed consent.
Key exclusion criteria
Patients who meet the following criteria:
(1)Less than 1 month since onset of myocardial infarction, unstable angina or peripheral artery disease.
(2) Patients with systemic embolism, or less than 3 month since onset of stroke.
(3) Patients with malignant tumor (no improvement in symptoms).
(4) Life expectancy of less than one year due to other pre-existing diseases.
(5) Patients judged as unsuitable for the study by study investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular, Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi,Tochigi, Japan 329-0498
TEL
0285-58-7538
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular, Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi,Tochigi, Japan 329-0498
TEL
0285-58-7538
Homepage URL
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
A&D Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee for Clinical Research, Jichi Medical University Hospital
Address
3311-1 Yakushiji, Shimotsuke-shi,Tochigi, Japan
Tel
0285-58-8933
rinri@jichi.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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 04 | Day |
Last modified on
| 2022 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037928
