UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015886 |
|---|---|
| Receipt number | R000018488 |
| Scientific Title | Relationship between pressure and flow velocity on coronary physiology |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2014/12/10 13:31:25 |
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Basic information
Public title
Relationship between pressure and flow velocity on coronary physiology
Acronym
Relationship between pressure and flow velocity on coronary physiology
Scientific Title
Relationship between pressure and flow velocity on coronary physiology
Scientific Title:Acronym
Relationship between pressure and flow velocity on coronary physiology
Region
| Japan |
Condition
Condition
A patient who are planned to do PCI for coronary stenosis in LCX without other stenosis in LAD and RCA, or a patient with normal coronary artery
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of coronary hemodynamics by distribution of coronary
pressure, flow velocity and morphology in each coronary segment
Basic objectives2
Others
Basic objectives -Others
Evaluatuion of coronary physiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coronary pressure, flow velosity, wave intensity and vessel diameter in LAD and RCA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Evaluation of coronary pressure, flow velocity, wave intensity and vessel morphology by using a pressure/Doppler sensor-tipped-guidewire and intravascular ultrasound
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient who are planned to do PCI for coronary stenosis in LCX without other stenosis in LAD and RCA, or a patient with normal coronary artery
Key exclusion criteria
1)A patient with coronary stenosis with LAD
2)Hemodialysis
3)Acute coronary syndrome
4)congestive heart failure
5)A ptient with shock vitals
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Masuyama |
Organization
Hyogo College of Medicine
Division name
Cardiovascular Division
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL
0798456553
masuyama@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroto Tamaru |
Organization
Hyogo College of Medicine
Division name
Cardiovascular Division
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL
0798456553
Homepage URL
hirototamaru@yahoo.co.jp
Sponsor or person
Institute
Cardiovascular Division, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine Division of Cardiology
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
| 2014 | Year | 12 | Month | 10 | 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
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | 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
| 2014 | Year | 12 | Month | 09 | Day |
Last modified on
| 2014 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018488
