UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049938 |
|---|---|
| Receipt number | R000056876 |
| Scientific Title | Development of Community-based Digital Cardiovascular Risk Prevention Network System with Blood Pressure Telemonitoring. |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/28 14:44:27 |
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Basic information
Public title
Development of Community-based Digital Cardiovascular Risk Prevention Network System with Blood Pressure Telemonitoring.
Acronym
DI-CAP
Scientific Title
Development of Community-based Digital Cardiovascular Risk Prevention Network System with Blood Pressure Telemonitoring.
Scientific Title:Acronym
DI-CAP
Region
| Japan |
Condition
Condition
Stroke, myocardial infarction, angina pectoris, aortic dissection, peripheral artery disease, heart failure, diabetes, hyperlipidemia, hypertension, chronic kidney disease, atrial fibrillation, sleep apnea syndrome, chronic obstructive pulmonary disease, hyperuricemia, obesity, Parkinson's disease, dementia with Lewy bodies and cerebrovascular dementia.
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine the causes of blood pressure fluctuations and prevent the onset and severity of cardiovascular disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure, diastolic blood pressure and heart rate.
Key secondary outcomes
Relationship between the blood pressure and following:
1) Organ damage and cardiovascular events
2) Lifestyle and housing condition
3) Cognitive function and frailty
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
1. Patients with at least one cardiovascular risk factors, history of cardiovascular disease, or autonomic nervous dysfunction
2. Aged 20 years or older at time of giving consent
Key exclusion criteria
1. History of stroke within 6 months.
2. Dialysis patient
3. Patients undergoing treatment for other serious diseases (cancer, collagen disease, etc.)
Target sample size
500
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, Tochigi, 329-0498, JAPAN
TEL
0285-58-7538
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hoshide |
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, Tochigi, 329-0498, JAPAN
TEL
0285-44-2130
Homepage URL
hoshide@jici.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Foundation for Development of the Community
Japan Society for the Promotion of Science [Grant-in-Aid for Scientific Research (C)]
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Bioethics Committee for Clinical Research
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, 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
南三陸病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 28 | 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
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Methods:
Participants will continuously measure home blood pressure and room temperature. During the study period, the medical information, such as diagnosis of cardiovascular events, prescriptions and office BPs will be collected from their medical records.
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056876
| 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 |
