UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039178 |
|---|---|
| Receipt number | 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 16:52:46 |
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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
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
hideyayamamoto-circ@umin.ac.jp
Sponsor or person
Institute
Faculty of Pharmacy, Yasuda Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044415
