UMIN-CTR Clinical Trial

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
Last 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
Email	tkudo123@nagasaki-u.ac.jp

Public contact
1st 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
Email	tkudo123@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024969