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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018552
Receipt No. R000020922
Scientific Title Screening of cardiovascular, cerebrovascular, and renal disease for residents in rural areas using a medical IT network
Date of disclosure of the study information 2015/08/05
Last modified on 2018/02/09

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Basic information
Public title Screening of cardiovascular, cerebrovascular, and renal disease for residents in rural areas using a medical IT network
Acronym Screening of disease for residents in rural areas using a medical IT network
Scientific Title Screening of cardiovascular, cerebrovascular, and renal disease for residents in rural areas using a medical IT network
Scientific Title:Acronym Screening of disease for residents in rural areas using a medical IT network
Region
Japan

Condition
Condition cardiovascular disease, cerebrovascular disease, renal disease
Classification by specialty
Cardiology Nephrology Neurology
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To formulate the guideline to improve prognosis of residents in rural areas by intervention by specialists via medical information network
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of incidence of cardiovascular, cerebrovascular, or renal diseases between residents in rural areas with intervention by specialists via the medical information network and those without the intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment Other
Interventions/Control_1 Intervention group gets advices from specialists in Sendai area via medical information network.
Interventions/Control_2 Non-intervention group is followed up by doctors in each area.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Men and women living in other than Sendai area aged 65 years or over with low or middle risk for cardiovascular diseases determined by existing guidelines
Key exclusion criteria -Patients with history of stroke, myocardial infarction, or severe cardiovascular diseases within six month
-BNP is 200pg/mL or over
-eGFR is less than 30mL/min/1.73m2 or albumin creatinine ratio in urin is 300mg/gCr or over
-Patient ineligible to this study due to other medical reasons
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Nakayama
Organization Tohoku University
Division name Department of Medical Informatics, Tohoku University School of Medicine
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-7572
Email nakayama@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaharu Nakayama
Organization Tohoku University
Division name Department of Medical Informatics, Tohoku University School of Medicine
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-7572
Homepage URL
Email nakayama@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Akita University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 08 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
2015 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients meeting exclusion criteria are not included in the intervention trial, and they are included in the observational study. The patients at high risk are encouraged to visit specialists at the beginning of observation. The subjects are followed up after six month, and if they do not visit specialists, they are encouraged to visit specialists again. They are followed up after one year, and data on outcome are collected.

Management information
Registered date
2015 Year 08 Month 05 Day
Last modified on
2018 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020922

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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