臨床研究等提出・公開システム

Date of registration	April. 12, 2021
Last modified on	July. 14, 2022
Trial ID	jRCT2032210032

Scientific Title	Phase III clinical trial to evaluate the diagnostic accuracy of QFR (Quantitative Flow Ratio) using online measurement
Public Title	Phase III clinical trial to evaluate the diagnostic accuracy of QFR

Completion date	Mar. 10, 2022
Result actual enrolment	186
Baseline Characteristics	Mean age 70.8, Male 78.9%, Mean pulse rate 70.0 bpm, Mean LV EF 60.2
Participant flow	After 14 days screening period participants went under CAG or PCI in which FFR and QFR were measured. Participants were followed up until the day of discharge.
Adverse events	Adverse events in 18/186 patients (9.7%), 24 cases Mild 8, moderate 16, serious 0
Outcome measures	Diagnostic accuracy of QFR in comparison with FFR as gold standard of functional assessment (Full Analysis Set) Sensitivity 90.6, Specificity 89.0, Positive predictive value 86.5, Negative predictive value 92.4 Average time to FFR 11.25 minutes, Average time to QFR 6.34 minutes
Brief summary	QFR showed high diagnostic accuracy in comparison with FFR as gold standard of functional assessment of coronary arteries.

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT2032210032

Contact for Scientific Queries	Name	van Schaik-Yamamoto Yuko
	Affiliation	M&S
	Address	3rd floor, 5-1 Nihonbashi Kabutocho, Chuo-ku, Tokyo
	Telephone	+81-9086023560
	E-mail	YVanschaik@medisimaging.com
Contact for Public Queries	Name	van Schaik-Yamamoto Yuko
	Affiliation	Medis medical imaging systems
	Address	3rd floor, 5-1 Nihonbashi Kabutocho, Chuo-ku, Tokyo
	Telephone	+81-3-6778-2589
	E-mail	YVanschaik@medisimaging.com

Recruitment status	Complete

Anticipated date of first enrollment		April. 19, 2021
Actual date of first enrollment		May. 25, 2021
Target sample size		191
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients with stable angina or patients who undergo a secondary assessment of stenosis after AMI - 20 years of age or older - Patients who can give written consent to the participation
	Exclusion Criteria	- Patients who had myocardial infarction within 72 hours - Patients with severe asthma or severe chronic obstructive pulmonary disease - Patients with severe heart failure
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Stable angina or stenosis after AMI
Intervention(s)		FFR will be measured during coronary angiography or coronary intervention in the patients who gave written consent. QFR will be measured by a certified user for all vessels for which FFR assessment is planed. Patients will be treated according to the results of angiography and FFR. QFR values should not be used to determine treatment strategy.
Primary Outcome(s)		Evaluate the diagnostic accuracy of QFR with FFR as gold standard, and compare the diagnostic accuracy of QFR with that of anatomical assessment by QCA.

Primary Sponsor	Medis medical imaging systems

Name of Certified Review Board	Wakayama Medical University IRB
Address	811-1 Kimiidera, Wakayama-shi, Wakayama
Telephone	+81-73-441-0547
E-Mail	chiken@wakayama-med.ac.jp
Approval Status	Approval
Date of approval	April. 28, 2021

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	July. 14, 2022	(this page)	Changes
3	Oct. 20, 2021	Detail	Changes
2	May. 31, 2021	Detail	Changes
1	April. 12, 2021	Detail

List of change history