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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039178
Receipt No. R000044415
Scientific Title Multicenter Study for Evaluation of Coronary Artery Calcium Using Non-ECG Gated Chest CT
Date of disclosure of the study information 2020/05/01
Last modified on 2020/03/03

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Basic information
Public title Multicenter Study for Evaluation of Coronary Artery Calcium Using Non-ECG Gated Chest CT
Acronym Multicenter Study for Evaluation of Coronary Artery Calcium Using Non-ECG Gated Chest CT
Scientific Title Multicenter Study for Evaluation of Coronary Artery Calcium Using Non-ECG Gated Chest CT
Scientific Title:Acronym Multicenter Study for Evaluation of Coronary Artery Calcium Using Non-ECG Gated Chest CT
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine whether Non-ECG triggered coronary calcium score is clinically useful to identify obstructive CAD. We elucidate new coronary calcium scoring method to estimate coronary risks.

Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes non-inferiority to ECG triggering coronary calcium scoring for detection of obstructive coronary artery disease
Key secondary outcomes Validation of novel method to detect coronary artery disease using automated intelligence

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
100 years-old >
Gender Male and Female
Key inclusion criteria Patients who undergo scheduled coronary computed tomography angiography
Key exclusion criteria prior coronary revascularization, prior myocardial infarction, prior treated structure heart disease, status acute coronary syndrome or other urgent status, NYHA class IV severer heart failure, prior device tmplantation
BMI >= 30 km/m2
inadequate image quality
Target sample size 106

Research contact person
Name of lead principal investigator
1st name Hideya
Middle name
Last name Yamamoto
Organization Faculty of Pharmacy, Yasuda Women's University
Division name Laboratory of Physiology and Morphology,
Zip code 7310153
Address Yasuhigashi 6-13-1 Asa-Minami Hiroshima-city
TEL 09034205658
Email hideyayamamoto-circ@umin.ac.jp

Public contact
Name of contact person
1st name Hideya
Middle name
Last name Yamamoto
Organization Faculty of Pharmacy, Yasuda Women's University
Division name Laboratory of Physiology and Morphology,
Zip code 7310153
Address Yasuhigashi 6-13-1 Asa-Minami Hiroshima-city
TEL 09034205658
Homepage URL
Email hideyayamamoto-circ@umin.ac.jp

Sponsor
Institute Faculty of Pharmacy, Yasuda Women's University
Institute
Department

Funding Source
Organization Faculty of Pharmacy, Yasuda Women's University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Faculty of Pharmacy, Yasuda Women's University
Address Yasuhigashi 6-13-1 Asa-Minami Hiroshima-city
Tel 0828789440
Email yamamoto-h@yasuda-u.ac.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
2020 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information pending

Management information
Registered date
2020 Year 01 Month 16 Day
Last modified on
2020 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044415

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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