UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013953 |
|---|---|
| Receipt number | R000016227 |
| Scientific Title | Diagnostic performance of dual-energy coronary CT angiography for coronary artery stenosis using invasive coronary angiography as reference |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2017/08/04 09:47:53 |
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Basic information
Public title
Diagnostic performance of dual-energy coronary CT angiography for coronary artery stenosis using invasive coronary angiography as reference
Acronym
Diagnostic performance of dual-energy coronary CT angiography for coronary artery stenosis using invasive coronary angiography as reference
Scientific Title
Diagnostic performance of dual-energy coronary CT angiography for coronary artery stenosis using invasive coronary angiography as reference
Scientific Title:Acronym
Diagnostic performance of dual-energy coronary CT angiography for coronary artery stenosis using invasive coronary angiography as reference
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic performance of dual-energy coronary CT angiography (CCTA) with that of conventional single-energy CCTA for coronary artery stenosis using invasive coronary angiography as a gold standard.
Basic objectives2
Others
Basic objectives -Others
Diagnostic performance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coronary artery stenosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional single-energy coronary CT angiography
Interventions/Control_2
Dual-energy coronary CT angiography
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age equal to or more than 20 years
2. Scheduled to undergo a clinically indicated invasive coronary angiography (ICA)
3. underwent or agree to undergo coronary CT angiography with equal to or more than 64 multidetector row CT within 90 days before or after ICA
4. Heart rate at coronary CT andiography equal to or lower than 65 beats per minute
Key exclusion criteria
1. Prior coronary artery bypass graft (CABG) surgery
2. Contraindication to beta blocker agents, nitrates, or adenosine
3. Recent prior myocardial infarction
4. Prior pacemaker or internal defibrillator lead implantation
5. Tachycardia or significant arrhythmia
6. Impaired chronic renal function (serum creatinine >1.5 mg/dl)
7. Subjects with known anaphylactic allergy to iodinated contrast material
8. Pregnancy or unknown pregnancy status in subject of childbearing potential
9. Subject requires an emergent procedure
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Jinzaki |
Organization
Keio University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1211(+81-3-3353-1211)
jinzaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitake Yamada |
Organization
Keio University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1211(+81-3-3353-1211)
Homepage URL
yamada@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
GE Healthcare
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 07 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 14 | Day |
Last modified on
| 2017 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016227
