UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001577 |
|---|---|
| Receipt number | R000001900 |
| Scientific Title | Nationwide Gender-specific Atherosclerosis Determinants Estimation and Ischemic Cardiovascular Disease Prospective Cohort Study |
| Date of disclosure of the study information | 2008/12/15 |
| Last modified on | 2020/12/26 01:52:00 |
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Basic information
Public title
Nationwide Gender-specific Atherosclerosis Determinants Estimation and Ischemic Cardiovascular Disease Prospective Cohort Study
Acronym
NADESICO study
Scientific Title
Nationwide Gender-specific Atherosclerosis Determinants Estimation and Ischemic Cardiovascular Disease Prospective Cohort Study
Scientific Title:Acronym
NADESICO study
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the hypothesis that coronary diseases of women are related, in the manner different to men, with risk factors such as hypertension, diabetes, dyslipidemia, obesity and smoking.
Basic objectives2
Others
Basic objectives -Others
Verification of the hypothesis that women with coronary lesions including stenosis and calcification will less suffer from cardiovascular diseases and death than men.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Coronary stenosis and coronary wall characteristics including plaques, calcifications and lipid storages.
Key secondary outcomes
Cardiovascular diseases and related deaths
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient who carried out a simple coronary artery CT scan and coronary angiography CT inspection (beyond 64 lines or channels) with the doubt of the coronary artery disease.
Key exclusion criteria
(1) a person with the past history of the coronary artery revascularization (PCI and CABG). But, patient to schedule a coronary artery revascularization method from now isn't excluded.
(2) a patient with Kawasaki diseases.
(3) a patient with coronary artery deformity.
(4) a person with familial hypercholesterolemia.
(5) a patient whose prognosis is obviously restricted by cancer.
(6) a patient with dialysis.
(7) a patient with a serious psychological or neurological disease.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Teruo |
| Middle name | |
| Last name | Noguchi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1, Kishibeshimmachi, Suita, Osaka, Japan.
TEL
06-6170-1070
tnoguchi@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwanaga |
Organization
National Cerebral and Cardiovascular Center
Division name
Open Innovation Center
Zip code
564-8565
Address
6-1, Kishibeshimmachi, Suita, Osaka, Japan.
TEL
06-6170-1070
Homepage URL
http://nadesico.ncvc.go.jp/
yiwanaga@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1, Kishibeshimmachi, Suita, Osaka, Japan.
Tel
06-6170-1070
rec-office-ac@ncvc.go.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
| 2008 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
http://nadesico-study.com
Publication of results
Partially published
Result
URL related to results and publications
http://www.ncvc.go.jp/pr/release/20180215_press.html
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
| 2008 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
https://www.amed.go.jp/news/release_20180215-02.html
Management information
Registered date
| 2008 | Year | 12 | Month | 15 | Day |
Last modified on
| 2020 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001900
