UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020360 |
|---|---|
| Receipt number | R000023517 |
| Scientific Title | Efficacy of invasive and non-invasive coronary imaging for evaluation of myocardial ischemia in intermediate coronary stenosis -Multicenter observational study- |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2020/12/30 22:37:07 |
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Basic information
Public title
Efficacy of invasive and non-invasive coronary imaging for evaluation of myocardial ischemia in intermediate coronary stenosis -Multicenter observational study-
Acronym
Efficacy of invasive and non-invasive coronary imaging for evaluation of myocardial ischemia in intermediate coronary stenosis -Multicenter observational study-
Scientific Title
Efficacy of invasive and non-invasive coronary imaging for evaluation of myocardial ischemia in intermediate coronary stenosis -Multicenter observational study-
Scientific Title:Acronym
Efficacy of invasive and non-invasive coronary imaging for evaluation of myocardial ischemia in intermediate coronary stenosis -Multicenter observational study-
Region
| Japan |
Condition
Condition
Stable or unstable angina with intermediate coronary stenosis by coronary angiography or coronary CT angiography
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of invasive coronary imaging to estimate myocardial ischemia in patients with coronary artery disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison between fractional flow reserve and invasive coronary imaging for evaluation of myocardial ischemia in intermediate coronary stenosis
Key secondary outcomes
Relationship between invasive / non-invasive coronary imaging and prognostic significance
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with stable or unstable angina.
Patients with intermediate coronary stenosis (30-70%).
Patients who performed coronary imaging (IVUS/OCT), fractional flow reserve (FFR) and non-invasive coronary CT angiography
Key exclusion criteria
Patients with cardiac arrest or cardiogenic shock.
Restenosis within stent or CABG graft failure.
Severe calcification.
Vessel size<2.5mm or >5mm.
LVEF<30%
Serum Creatinine >2.0
Inappropriate decision by doctors
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shinjo |
| Middle name | |
| Last name | Sonoda |
Organization
University of Occupational and Environmental Health
Division name
Cardiovascular medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL
093-691-7250
sonoda-sgy@umin.net
Public contact
Name of contact person
| 1st name | Shinjo |
| Middle name | |
| Last name | Sonoda |
Organization
University of Occupational and Environmental Health
Division name
Cardiovascular medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL
093-691-7250
Homepage URL
sonoda-sgy@umin.net
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee in the University of occupational and environmental health
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu
Tel
093-603-1611
j-gairon@mbox.med.uoeh-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
| 2016 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: cohort study
Management information
Registered date
| 2015 | Year | 12 | Month | 26 | Day |
Last modified on
| 2020 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023517
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
