UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018790 |
|---|---|
| Receipt number | R000021738 |
| Scientific Title | Evaluation of software for diagnosis of coronary artery disease |
| Date of disclosure of the study information | 2015/09/15 |
| Last modified on | 2015/08/24 22:46:29 |
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Basic information
Public title
Evaluation of software for diagnosis of coronary artery disease
Acronym
Evaluation of software for diagnosis of coronary artery disease
Scientific Title
Evaluation of software for diagnosis of coronary artery disease
Scientific Title:Acronym
Evaluation of software for diagnosis of coronary artery disease
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the accuracy of software measuring FFR by coronary angiography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
concordance rate of FFR value measured with pressure wire and FFR value estimated by the software
Key secondary outcomes
Investigation of influence factors for concordance rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients who undertake measurement of FFR
2) patients with stable angina pectoris
3) patients who are over 20 years old when informed consent are collected
4) patients from whom informed consent are collected with adequate understanding of the research
Key exclusion criteria
1) patients who undertake measurement of FFR
2) patients under medical treatments for cerebral hemorrhages in acute phase
3) patients with bronchial asthma
4) patients whom primary investigators or sub investigators decide to exclude because of inadequacies for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Ando |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL
+81-3-3815-5411
jando-kkr@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Ando |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL
+81-3-3815-5411
Homepage URL
jando-kkr@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Siemens Japan K.K
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 09 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation for concordance rate of FFR value measured with pressure wire and FFR value estimated by the software
Investigation of influence factors for concordance rate
Management information
Registered date
| 2015 | Year | 08 | Month | 24 | Day |
Last modified on
| 2015 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021738
