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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031662
Receipt No. 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 2018/12/27

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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
Email 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
Email t.fushimi0223@gmail.com

Sponsor
Institute Medical corporation Okinawa tokusukai Shonan Kamakura general hospital (clinical research center)
Institute
Department

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
Email

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
Results
There was no significant difference between the maximum value-minimum value, dispersion value, standard deviation, average value of three measurements with 2.5 cc and 5 cc syringe at rest and load.
As for the number of errors, a significant difference was obtained only at rest.
However, the measured value at 2.5 cc tended to be smaller.
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
2017 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
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
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036164

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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