UMIN-CTR Clinical Trial

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

Contact us.