UMIN-CTR Clinical Trial

Basic information
Public title	The Utility of Exercise-induced Hyperemia for the Measurement of Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Acronym	Exercise-induced Hyperemia for the Measurement of Fractional Flow Reserve
Scientific Title	The Utility of Exercise-induced Hyperemia for the Measurement of Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Scientific Title:Acronym	Exercise-induced Hyperemia for the Measurement of Fractional Flow Reserve
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to investigate the usefulness of exercise-induced hyperemia as a method of inducing hyperemia compared with pharmacological hyperemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FFR value measured by exercise-induced hyperemia compared with drug-induced hyperemia
Key secondary outcomes	heart rate, blood pressure, and cardiac ultrasound data before and after exercise

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	2mg of intracoronary nicorandil
Interventions/Control_2	2mg of intracoronary nicorandil after dynamic handgrip contraction (1/s) for 90s at 60% maximal voluntary contraction
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who have at least one of 50 to 90% focal stenosis in the coronary artery on diagnostic coronary angiography.
Key exclusion criteria	acute coronary syndrome significant left main disease lesion with chronic total occlusion or collateral vessel previous coronary artery bypass surgery severe valvular disease low ejection fraction severe renal dysfunction or hemodialysis contraindications of exercise
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Shibutani
Organization	Kansai Medical University
Division name	Department of Medicine 2
Zip code	573-1010
Address	2-5-1, Shinmachi, Hirakata City, Osaka
TEL	072-804-0101
Email	hs.vxvii@gmail.com

Public contact
Name of contact person	1st name Hiroki Middle name Last name Shibutani
Organization	Kansai Medical University
Division name	Department of Medicine 2
Zip code	573-1010
Address	2-5-1, Shinmachi, Hirakata City, Osaka
TEL	072-804-0101
Homepage URL
Email	hs.vxvii@gmail.com

Sponsor
Institute	Kansai Medical University
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	Kansai Medical University Hospital Ethics Review Committee
Address	2-5-1, Shin-machi, Hirakata, Osaka
Tel	072-804-0101
Email	rinriirb@hirakata.kmu.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	2019 Year 02 Month 08 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	24
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	Completed
Date of protocol fixation	2018 Year 11 Month 01 Day
Date of IRB	2019 Year 01 Month 07 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2020 Year 03 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	2019 Year 02 Month 06 Day
Last modified on	2021 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040155