UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035785 |
|---|---|
| Receipt number | R000040155 |
| Scientific Title | 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 | 2021/02/07 13:37:37 |
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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
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
hs.vxvii@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040155
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
