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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001577
Receipt No. 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

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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
Email 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/
Email yiwanaga@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
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 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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001900

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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