UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056925 |
|---|---|
| Receipt number | R000064467 |
| Scientific Title | A prognostic study using health insurance claim for patients with cardiovascular disease in Niigata -retrospective study- |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2024/12/10 19:52:14 |
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Basic information
Public title
A prognostic study using health insurance claim for patients with cardiovascular disease in Niigata -retrospective study-
Acronym
A prognostic study for patients with cardiovascular disease in Niigata
Scientific Title
A prognostic study using health insurance claim for patients with cardiovascular disease in Niigata -retrospective study-
Scientific Title:Acronym
Ni-HiCard retro study
Region
| Japan |
Condition
Condition
Patients with cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this molecular epidemiology cohort study is to contribute to the maintenance and promotion of national health, in particular to elucidating the causes and nature of heart disease, and to generating evidence for prevention and treatment that takes into account environmental factors, constitutions, and their interactions, as well as disease characteristics.
Basic objectives2
Others
Basic objectives -Others
Epidemiological survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death, hospitalization for heart failure, and worsening heart failure
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. People aged 18 or older who live in Niigata Prefecture (regardless of gender)
2. People who have medical or nursing care receipts issued between January 1, 2018 and December 31, 2057, or who have undergone a specific medical examination.
3. People who use the National Health Insurance or the Medical Care System for the Elderly.
Key exclusion criteria
None
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Inomata |
Organization
Niigata university
Division name
Cardiology
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL
0252272185
inotaka@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Fujiki |
Organization
Niigata University
Division name
Cardiology
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL
0252272185
Homepage URL
shinya_fukuji@yahoo.co.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku
Tel
025-227-2625
ethics@adm.niigata-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2044 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A detailed prognosis of the target patients will be investigated using medical examination and insurance claim data held by Niigata Prefecture in the "Niigata New Generation Healthcare Information Infrastructure"
Management information
Registered date
| 2025 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064467
