UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054854 |
|---|---|
| Receipt number | R000062672 |
| Scientific Title | Research for the diagnosis and prognosis of cardiovascular diseases using data of DPC and DWH |
| Date of disclosure of the study information | 2024/07/02 |
| Last modified on | 2024/07/02 14:28:35 |
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Basic information
Public title
Research for the treatment of cardiovascular diseases using data of databases
Acronym
Cardiovascular database research
Scientific Title
Research for the diagnosis and prognosis of cardiovascular diseases using data of DPC and DWH
Scientific Title:Acronym
Cardiovascular DPC database research
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to improve the quality of cardiovascular care by constructing an integrated DPC/DWH database that encompasses the cardiology departments of the four Nippon Medical School affiliated hospitals and by understanding actual medical practice and evaluating prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiovascular events
Key secondary outcomes
Risk factors of major adverse cardiovascular event by cardiovascular disease stratification
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were admitted to the Department of Cardiology at the four Nippon Medical School affiliated hospitals, the Department of Cardiovascular Intensive Care at the Nippon Medical School hospitals, or the Intensive Care Unit at Nippon Medical School Chiba Hokusoh Hospital between April 1, 2018 and March 31, 2028.
Key exclusion criteria
1. Those who have requested to refuse to participate in this study
2. Those who are otherwise deemed inappropriate for participation in this study by the principal investigator or co-investigators
Target sample size
47000
Research contact person
Name of lead principal investigator
| 1st name | Kuniya |
| Middle name | |
| Last name | Asai |
Organization
Nippon Medical School Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan.
TEL
03-3822-2131
kasai@nms.ac.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Tara |
Organization
Nippon Medical School Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan.
TEL
03-3822-2131
Homepage URL
s5062@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
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
Central Ethics Committee, Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan.
Tel
03-3822-2131
c-ethics@nms.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
| 2024 | Year | 07 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062672
