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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021357
Receipt No. R000024611
Scientific Title Prediction of functional significance of intermediate coronary artery stenosis assessed by fractional flow reserve, using intracoronary saline injection
Date of disclosure of the study information 2016/03/05
Last modified on 2021/03/09

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Basic information
Public title Prediction of functional significance of intermediate coronary artery stenosis assessed by fractional flow reserve, using intracoronary saline injection
Acronym Prediction of fractional coronary flow reserve by intracoronary saline injection
Scientific Title Prediction of functional significance of intermediate coronary artery stenosis assessed by fractional flow reserve, using intracoronary saline injection
Scientific Title:Acronym Prediction of fractional coronary flow reserve by intracoronary saline injection
Region
Japan

Condition
Condition angina pectoris
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Fractional floe reserve(FFR) has been recognized as an important examination to decide indication of perctaneous coronary intervention(PCI). We are going to demonstrate the usability of intracoronary saline injection(saline induced FFR;sFFR) as an easier and safer method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To determine sFFR cutoff value predicting FFR<0.8.
Key secondary outcomes To evaluate the safety of sFFR.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Just after coronary angiography, we insert a FFR wire into the coronary artery in the patients with intermediate coronary artery stenosis.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with intermediate coronary artery stenosis on CAG
Key exclusion criteria patients who are not excepted for current FFR examination.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshiharu
Middle name
Last name Fujimori
Organization Suwa Central Hospital
Division name Department of Cardiology
Zip code 391-8503
Address 4300 Tamagawa, Chino city, Nagano
TEL 0266-72-1000
Email fujimori.yoshiharu@gmail.com

Public contact
Name of contact person
1st name Yoshinharu
Middle name
Last name Fujimori
Organization Suwa Central Hospital
Division name Department of Cardiology
Zip code 391-8503
Address 4300 Tamagawa, Chino city, Nagano
TEL 0366-72-1000
Homepage URL
Email fujimori.yoshiharu@gmail.com

Sponsor
Institute Department of Cardiology, Suwa Central Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization none

Other related organizations
Co-sponsor Syowainan general Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Committee of Suwa Central Hospital
Address 4300 Tamagawa, Chino city, Nagano
Tel 0266-72-1000
Email byouin@suwachuo.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 昭和伊南病院(長野県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 05 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 Open public recruiting
Date of protocol fixation
2015 Year 07 Month 18 Day
Date of IRB
2015 Year 07 Month 28 Day
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2025 Year 08 Month 01 Day
Date of closure to data entry
2026 Year 01 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 05 Day
Last modified on
2021 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024611

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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