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

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 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

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

Value
https://center6.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