UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009713 |
|---|---|
| Receipt number | 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 18:55:59 |
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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
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
gucci_0418@yahoo.co.jp
Sponsor or person
Institute
Aoyama Hospital, Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009850
