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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035785
Receipt No. R000040155
Official scientific title of the study The Utility of Exercise-induced Hyperemia for the Measurement of Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Date of disclosure of the study information 2019/02/08
Last modified on 2019/02/06

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Basic information
Official scientific title of the study The Utility of Exercise-induced Hyperemia for the Measurement of Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Title of the study (Brief title) 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 Hiroki Shibutani
Organization Kansai Medical University
Division name Department of Medicine 2
Address 2-5-1, Shinmachi, Hirakata City, Osaka
TEL 072-804-0101
Email hs.vxvii@gmail.com

Public contact
Name of contact person Hiroki Shibutani
Organization Kansai Medical University
Division name Department of Medicine 2
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 11 Month 01 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 02 Month 06 Day
Last modified on
2019 Year 02 Month 06 Day


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

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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