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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039397
Receipt No. R000037570
Scientific Title The Accuracy of saline-induced FFR(sFFR) instead of fractional flow reserve(FFR) to evaluate the severity of coronary stenosis.
Date of disclosure of the study information 2020/02/05
Last modified on 2020/02/07

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Basic information
Public title The Accuracy of saline-induced FFR(sFFR) instead of fractional flow reserve(FFR) to evaluate the severity of coronary stenosis.
Acronym The correlation between sFFR and FFR
Scientific Title The Accuracy of saline-induced FFR(sFFR) instead of fractional flow reserve(FFR) to evaluate the severity of coronary stenosis.
Scientific Title:Acronym The correlation between sFFR and FFR
Region
Japan

Condition
Condition coronary stenosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the accuracy and the security of saline-induced FFR in which saline is injected rapidly to the target coronary vessel.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The accuracy of saline-induced FFR
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Food Device,equipment
Interventions/Control_1 Adding sailne-induce FFR during coronary angiography with FFR & SFR
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

Not applicable
Gender Male and Female
Key inclusion criteria Primary registration
Patients with coronary angiography for coronary stenosis
Secondary registration
1 Patients with coronary artery disease who undergo coronary angiography and judged having stenosis with 50% or more by 2 interventionists (at least one of them including specialists in Japanese Association of Cardiovascular Intervention and Therapeutics)

2 no particular limitation of the lesion site (left anterior descending artery, left circumflex branch, right coronary artery), history of PCI, and lesion form (in stent restenosis, calcified lesion)
3 over 20 years old
4 patients obtained document consents by the patient's will with sufficient understanding after receiving sufficient explanation for the participation of this study
Key exclusion criteria 1) Patients with severe valvular disease
2) Patients with decompensated heart failure
3) Patients with extreme bradycardia (HR <40 or less)
4) Patients who can not use Adenosine necessary for FFR
5) Patients with co-morbidities such as acute liver injury and renal disorder that have serious effects on life
6) coronary total occlusion
7) Patients who are judged inappropriate for participation in this study by the responsible doctor


Target sample size 300

Research contact person
Name of lead principal investigator
1st name Arihiro
Middle name
Last name Kiyosue
Organization The university of Tokyo Hospital
Division name Cardiovascular Medicine
Zip code 113-8655
Address Bunkyo-ku, Hongo, 7-3-1
TEL 03-3815-5411
Email kiyosuea-int@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Kiriyama
Organization The University of Tokyo Hospital
Division name Cardiovascular Medicine
Zip code 113-8655
Address Bunkyo-ku, Hongo, 7-3-1
TEL 03-3815-5411
Homepage URL
Email kiriyaman0427@gmail.com

Sponsor
Institute The university of Tokyo Hospital
Institute
Department

Funding Source
Organization The university of Tokyo Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Graduate School of Medicine and Faculty of Medicine, The University of Tokyo,Intervention Research Ethics Committee
Address Bunkyo-ku hongo 7-3-1, Tokyo, Japan
Tel 03-5841-0818
Email ethics@m.u-tokyo.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
2020 Year 02 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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 25 Day
Date of IRB
2019 Year 01 Month 29 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 02 Month 05 Day
Last modified on
2020 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037570

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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