UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021652 |
|---|---|
| Receipt number | R000024969 |
| Scientific Title | Improvement of diagnostic accuracy of heart disease using software |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2019/05/23 10:57:22 |
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Basic information
Public title
Improvement of diagnostic accuracy of heart disease using software
Acronym
Improvement of diagnostic accuracy using software
Scientific Title
Improvement of diagnostic accuracy of heart disease using software
Scientific Title:Acronym
Improvement of diagnostic accuracy using software
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diagnostic accuracy of heart disease using nuclear medicine imaging can be improved with software analytic technique such as phase analysis, cardiac function analysis etc. This study evaluates improvement of heart disease diagnostic accuracy using phase analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Phase disynchrony of myocardium
Key secondary outcomes
Systoric function. Diastoric function.
perfusion distribution.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who were performed stress myocardial perfusion nuclera medicine imaging from 2014/4/1 to 2016/1/30 for diagnosis of ischemic heart disease.
Key exclusion criteria
1) Patient with poor image quality due to heavy weight, extracardiac high activity etc.
2) Poor image reliability of ECG gated acquisition due to arrhytimia.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kudo |
Organization
Nagasaki University
Division name
Atomic Bomb Disease Institute
Zip code
8528523
Address
12-4 Sakamoto-1-chome, Nagasaki
TEL
095-819-7101
tkudo123@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | KUDO |
Organization
Nagasaki University
Division name
Atomic Bomb Disease Institute
Zip code
8528523
Address
12-4 Sakamoto-1-chome, Nagasaki
TEL
095-819-7101
Homepage URL
tkudo123@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
IRB of Nagasaki University Hospital
Address
1-12-4 Sakamoto
Tel
0958197229
gaibushikin@ml.nagasaki-u.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
| 2016 | Year | 03 | Month | 31 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Following information should be analyzed
1) Basic clinical information of patients.
2) Phase analysis parameter of patient should be compared between patients with and without ischemic finding on myocardial perfusion imaging.
3) Phase analysis parameter discordance between software used for phase analysis.
4) Relationship between severity of coronary artery disease and phase parameter, diastric/systoric function, perfusion analyzed on myocardial perfusion images.
Management information
Registered date
| 2016 | Year | 03 | Month | 28 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024969
