UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023517