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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009713
Receipt No. R000009850
Scientific Title Screening of Coronary Stenosis in Asympptomatic Adult with Coronary Calcifications by Coronary Computed Tomography Angiography.
Date of disclosure of the study information 2013/01/07
Last modified on 2014/08/07

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Basic information
Public title Screening of Coronary Stenosis in Asympptomatic Adult with Coronary Calcifications by Coronary Computed Tomography Angiography.
Acronym SOS-ACS
Scientific Title Screening of Coronary Stenosis in Asympptomatic Adult with Coronary Calcifications by Coronary Computed Tomography Angiography.
Scientific Title:Acronym SOS-ACS
Region
Japan

Condition
Condition Coronary Stenosis
Atherosclerosis
Classification by specialty
Medicine in general Cardiology Radiology
Laboratory medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the coronary stenosis with computed tomography coronary artery angiography in asymptomatic middle-aged subjects with coronary artery stenosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of the coronary artery stenosis and plaque
Key secondary outcomes The incidence of coronary artery plaque after 12 months.
The incidence of cardiac event within 24 months.

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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria The individual observed coronary artry calicification by computed tomography coronary artery angiography
Key exclusion criteria The individual who has a history of severe allergies to contrast media, a metformin within 48 hours of the study entry or chronic renal failure
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruki Sekiguchi
Organization Aoyama Hospital, Tokyo Women's Medical University
Division name Cardiology
Zip code
Address 2-7-13 Kita-Aoyama, Minato-ku, Tokyo, Japan
TEL +81-35411-8111
Email sekiguchi.haruki@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruki Sekiguchi
Organization Tokyo Women's Medical University
Division name Cardiology
Zip code
Address 8-1 Kawada-cho, Shinjyuku, Tokyo, Japan
TEL +81-33353-8111
Homepage URL
Email gucci_0418@yahoo.co.jp

Sponsor
Institute Aoyama Hospital, Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Aoyama Hospital, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Enrolling by invitation
Date of protocol fixation
2012 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective cohort study

Management information
Registered date
2013 Year 01 Month 07 Day
Last modified on
2014 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009850

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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