UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031662 |
|---|---|
| Receipt number | R000036164 |
| Scientific Title | About a fluctuation of the measure by the inculcation syringe change which is at the time of CFR measurement |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2020/05/20 20:05:28 |
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Basic information
Public title
About a fluctuation of the measure by the inculcation syringe change which is at the time of CFR measurement
Acronym
About a fluctuation of the measure by the inculcation syringe change which is at the time of CFR measurement
Scientific Title
About a fluctuation of the measure by the inculcation syringe change which is at the time of CFR measurement
Scientific Title:Acronym
About a fluctuation of the measure by the inculcation syringe change which is at the time of CFR measurement
Region
| Japan |
Condition
Condition
The degree of middle class coronary artery is narrow
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Looseness of the measure with the case when physiological saline was poured by 5 mL syringe in case of crown bloodstream spare ability measurement and the case poured by 2.5 mL syringe is performed by comparison by a standard deviation. The tendency of the measure is also considered.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluctuation of CFR value by the inculcation syringe change
Key secondary outcomes
The tendency of Tmn value in each syringe use time
Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
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
| Maneuver |
Interventions/Control_1
Physiological saline is poured by a syringe for 5 mL inculcation and a syringe for 2.5ml inculcation in case of CFR measurement.
Interventions/Control_2
An intervention period, once of CFR check implementation (I exchange an inculcation syringe for the time of rest and the time of an ATP load respectively and measure each 3 times.)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who judged that CFR measurement was necessary by the doctor who took charge of a CAG check
The patient who could get documentary consent by free will of the back and the patient person himself which had the enough explanation in case of participation of this research
Key exclusion criteria
1) patient with unstable angina which isn't also stabilized by medicine treatment [A stimulus lead restraint action and negative inotropic effect are reinforced, and there is a fear that the symptom does increase vice.]
2) patient with the degree of II or the degree of III bunch room block (except for the patient by whom an artificial pacemaker is loaded)
3) a remarkable cave of cave incomplete syndrome or a symptom, patient with a bradycardia (except for the patient by whom an artificial pacemaker is loaded) [There is a fear that the symptom does increase vice by a stimulus lead restraint action.]
4) patient with QT extended syndrome [When a bradycardia was manifested by a stimulus lead restraint action, there is a fear that I make them induce Torsades de pointes.]
5) patient with high low blood pressure [There is a fear that the symptom does increase vice by peripheral artery dilation effect.]
6) patient with heart failure in the decompensation state [The acuteness increase which is a heart failure by negative inotropic effect, there is a fear which leads to vice.]
7) the bronchus spasm by which it's for asthma, patient with a lung disease, patient with the past or patient with the question
8) the patient who has the medical history of the hyperesthesia to adenosine
9) the patient who judged that the doctor who does a hand skill was unsuitable as a subject of research person
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Fushimi |
Organization
Shonan Kamakura general hospital
Division name
Radiology
Zip code
Address
1370-1, Okamoto, Kamakura-shi, Kanagawa
TEL
0467-46-1717
t.fushimi0223@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Fushimi |
Organization
Shonan Kamakura general hospital
Division name
Radiology
Zip code
Address
1370-1, Okamoto, Kamakura-shi, Kanagawa
TEL
0467-46-1717
Homepage URL
t.fushimi0223@gmail.com
Sponsor or person
Institute
Medical corporation Okinawa tokusukai Shonan Kamakura general hospital (clinical research center)
Institute
Department
Personal name
Funding Source
Organization
NO
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
Address
Tel
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 | 01 | Month | 01 | 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
The value measured by the syringe of 2.5mL only the number of errors at rest with respect to Tmn was significantly less compared to the measurement at 5mL. At rest, both standard deviation at load, dispersion, the average value showed a low tendency 2.5mL syringe. In addition, cases that can not be measured with 5mL syringe was excluded there are three cases. The value of the 2.5mL syringe was significantly higher for the value of CFR.
Results date posted
| 2020 | Year | 05 | Month | 20 | Day |
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
| 2017 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036164
