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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020360
Receipt No. 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 2019/06/29

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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
Email 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
Email sonoda-sgy@umin.net

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023517

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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