UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013953
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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)
Email 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
Email yamada@rad.med.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016227

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.