臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 18, 2019
Last modified on	Aug. 31, 2021
Trial ID	jRCTs032180330

Scientific Title	Assessment of Fractional Flow Reserve Using Intraluminal Blood Speckle Observed by Integrated-Backscatter Intravascular Ultrasound (Assessment of Fractional Flow Reserve Using Intraluminal Blood Speckle Observed by Integrated-Backscatter Intravascular Ultrasound)
Public Title	Assessment of Fractional Flow Reserve by Intravascular Ultrasound (Assessment of Fractional Flow Reserve by Intravascular Ultrasound)

Completion date	April. 01, 2021
Result actual enrolment	8
Baseline Characteristics	Patients with stable coronary artery disease who are planned for percutaneous coronary intervention (7 men aged 68-84 years; 1 woman aged 63 years)
Participant flow	Registration 8 cases, Discontinuation 0 cases
Adverse events	None
Outcome measures	Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve (No analysis is performed)
Brief summary	A total of 8 patient have been included with no adverse event. However, because a software for intravascular ultrasound analysis (Terumo, Tokyo, Japan) was delayed, the enrollment was interrupted. The software was built in 2019, but was not applicable to our analysis. During the enrollment delay, a different study group has completed a similar investigation and published the results. Thus, the present study has been terminated on Apr 1st 2021. Because of the capability of software, no analysis is performed.
Date of posting of results summaries	Aug. 31, 2021
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	Not applicable
URL link to protocol file(s) with version and date	https://jrct.niph.go.jp/latest-detail/jRCTs032180330

Contact for Scientific Queries	Name	Kitahara Hideki
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana Chuo-ku, Chiba
	Telephone	+81-43-222-7171
	E-mail	hkitahara@chiba-u.jp
Contact for Public Queries	Name	Kitahara Hideki
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana Chuo-ku, Chiba
	Telephone	+81-43-222-7171
	E-mail	hkitahara@chiba-u.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 17, 2017
Actual date of first enrollment		April. 17, 2017
Target sample size		31
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with stable coronary artery disease who are scheduled to undergo percutaneous coronary intervention
	Exclusion Criteria	1. Patients with hemodialysis 2. Patients who are inhaled drugs or theophylline products for bronchial asthema 3. Patients with left main trunk lesion 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
	Age Minimum	20age old over
	Age Maximum	85age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Stable coronary artery disease
Intervention(s)		Anatomical assessment and measuring intensity of blood speckle using intravascular ultrasound, and physiological assessment during percutaneous coronary intervention
Health Condition(s) Keyword		Ischemic heart disease
Intervention(s) Keyword
Health Condition(s) Code		052
Intervention(s) Code
Primary Outcome(s)		Correlation between delta intensity of blood speckle and fractional flow reserve under basal condition and hyperemia
Secondary Outcome(s)		Diagnostic accuracy of delta intensity of blood speckle for fractional flow reserve less than or equal to 0.80 under basal condition and hyperemia

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval

Secondary ID(s)	UMIN No. 000026325
Issuing Authority	University hospital Medical Information Network (UMIN) Center

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Aug. 31, 2021	(this page)	Changes
3	April. 08, 2021	Detail	Changes
2	Oct. 26, 2020	Detail	Changes
1	Mar. 18, 2019	Detail

List of change history