UMIN-CTR Clinical Trial

Basic information
Public title	Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Acronym	Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Scientific Title	Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Scientific Title:Acronym	Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Region	Japan

Condition
Condition	Coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Basic objectives2	Others
Basic objectives -Others	Physiological assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison between the difference in intraluminal intensity of blood speckle (Delta IBS) and fractional flow reserve (FFR) with or without hyperemia.
Key secondary outcomes	1) Comparison between Delta IBS and instantaneous wave-free ratio (iFR) with or without hyperemia. 2) Diagnostic Accuracy of Delta IBS for physiological assessment of coronary artery stenosis by FFR with or without hyperemia. 3) Diagnostic Accuracy of Delta IBS for physiological assessment of coronary artery stenosis by iFR with or without hyperemia. 4) Diagnostic Accuracy of minimum lumen area (MLA) on intravascular ultrasound (IVUS) for physiological assessment of coronary artery stenosis.

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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	IVUS data acquisition and FFR measurement during percutaneous coronary intervention (PCI).
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 who scheduled to undergo PCI.
Key exclusion criteria	1) Patients with hemodialysis 2) Patients who use nhaled drugs or theophylline products for bronchial asthma 3) Patients with left main trunk lelsion or stenosis >50% at the distal to the target lesion. 4) Patients with chronic total obstruction 5) Patients with severe heart failure (ejection fraction <30% or NYHA >class 3) 6) Patients with prior coronary artery bypass grafting
Target sample size	31

Research contact person
Name of lead principal investigator	1st name Yoshio Middle name Last name Kobayashi
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	260-0856
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Email	a-tamiya@chiba-u.jp

Public contact
Name of contact person	1st name Yuichi Middle name Last name Saito
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	260-0856
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Homepage URL
Email	policemaccho@yahoo.co.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	None
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	Chiba University Hospital
Address	1-8-1 Inohana, Chuo-ku, Chiba
Tel	043-222-7171
Email	takeshis@faculty.chiba-u.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	2017 Year 03 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	2016 Year 11 Month 24 Day
Date of IRB	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 27 Day
Last modified on	2021 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030239