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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | ischemic heart disease | ||
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Target sample size | 2000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |