UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022294 |
|---|---|
| Receipt number | R000025689 |
| Scientific Title | Performance evaluation of cardioREPO in stress myocardial perfusion scintigraphy for patients with ischemic heart disease |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2016/06/09 07:37:50 |
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Basic information
Public title
Performance evaluation of cardioREPO in stress myocardial perfusion scintigraphy for patients with ischemic heart disease
Acronym
cardioREPO study
Scientific Title
Performance evaluation of cardioREPO in stress myocardial perfusion scintigraphy for patients with ischemic heart disease
Scientific Title:Acronym
cardioREPO study
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy of cardioREPO in coronary artery branch area (left anterior descending, left circumflex, right coronary artery), using image analysis of the myocardial perfusion scintigraphy for patients with ischemic heart disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase IV
Assessment
Primary outcomes
the diagnostic concordance rate of cardioREPO and QPS using the 17-segment defect score in myocardial perfusion SPECT
Key secondary outcomes
the sensitivity, specificity, and accuracy of cardioREPO based on the data from cardiac catheterization
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
use personal medical data of patients
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients undergoing stress myocardial perfusion SPECT
2)Patients agreeing with this study after informed concent
Key exclusion criteria
1)Patients who are contraindication to stress myocardial perfusion SPECT
2)patients judged not eligible in this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Miyauchi |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1, inohana, Chuo-ku, Chiba, JAPAN
TEL
043-222-7171
hmiyauchi-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Miyauchi |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1, inohana, Chuo-ku, Chiba, JAPAN
TEL
043-222-7171
Homepage URL
hmiyauchi-circ@umin.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM RI Pharma Co., Ltd.
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | 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
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
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | 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
| 2016 | Year | 05 | Month | 12 | Day |
Last modified on
| 2016 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025689
