UMIN-CTR Clinical Trial

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