UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019871 |
|---|---|
| Receipt number | R000022959 |
| Scientific Title | Prediction of ICT-Home blood Pressure Variability |
| Date of disclosure of the study information | 2015/11/20 |
| Last modified on | 2025/05/20 08:53:09 |
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Basic information
Public title
Prediction of ICT-Home blood Pressure Variability
Acronym
Predict Registry
Scientific Title
Prediction of ICT-Home blood Pressure Variability
Scientific Title:Acronym
Predict Registry
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to perform and follow home blood pressure measurement for two years by the home blood pressure device which can measure temperature of the measurement environment at the same time, and investigate a new blood pressure variability index more closely related with a cardiovascular disease and establish the algorithm to identify thermosensitive hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total mortality
Key secondary outcomes
Cardiovascular death, Sudden death, Ischemic heart disease, Cerebrovascular disease, De novo arteriosclerosis obliterans, Aortic dissection, heart failure that requires hospitalization, De novo diabetes, De novo atrial fibrillation, and Chronic hemodialysis
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
Patient with at least one of the following cardiovascular risk factor:
-Diabetes, glucose tolerance disorder (under the treatment with fasting blood-sugar level 110 mg/dl or above, 75gOGTT (in 2 hours level 140mg/dl or above) -Dyslipidemia (under the treatment or total cholesterol level above 240mg/dl) -Hypertension (under treatment or clinic blood pressure 140/90 mmHg or above)
-Current smoking
-Renal disease (positive proteinuria or serum creatinine level 1.1mg/dl or above)
-Atrial fibrillation
Key exclusion criteria
-Cerebral vascular disease within 6 months (except for asymptomatic or transient ischemic attack)
-Hemodialysis patients
-Having other severe diseases (cancer, connective tissue disease)
-Unwillingness to sign an informed consent.
-Patient him/herself or his/her family uses medical devices (e.g., pacemaker) which are affected by electric waves from mobile-phone.
-Patients considered as inappropriate to participate in this study by attending physicians.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498,Japan.
TEL
0285-58-7344
predict@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hoshide |
Organization
Jichi Medical University School
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498,Japan.
TEL
0285-58-7344
Homepage URL
predict@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School
Institute
Department
Personal name
Funding Source
Organization
Department of Sleep and Circadian Cardiology, 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
Jichi Medical University Hospital Clinical Research Ethics Committee
Address
3311-1, Yakushiji, Shimotsuke, 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）
鷲谷病院（栃木県）
東吾妻町国民健康保険診療所（群馬県）
沖縄県立中部病院（沖縄県）
宮城県公立南三陸診療所（宮城県）
広島市立安佐市民病院（広島県）
小竹町立病院（福岡県）
飯塚市立病院（福岡県）
大阪暁明館病院（大阪府）
市立大町総合病院（長野県）
昭和大学（東京都）
聖路加国際病院（東京都）
石黒クリニック（岐阜県）
やまもとクリニック（神奈川県）
中田医院（兵庫県）
鹿島内科クリニック（東京都）
佐久総合病院佐久医療センター（長野県）
国立病院機構 宮崎東病院（宮崎県）
うぶかた循環器クリニック（群馬県）
遠賀中間医師会 おんが病院（福岡県）
八代市立椎原診療所（熊本県）
馬渡島診療所（佐賀県）
北海道循環器病院（北海道）
春日井市民病院（愛知県）
福島県立医科大学会津医療センター（福島県）
医療法人 社団 竹山会 青木医院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 20 | 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
1036
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 | 10 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2015 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022959
