UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012848 |
|---|---|
| Receipt number | R000011810 |
| Scientific Title | Validation of nuclear myocardial perfusion imaging system using a multifocal collimator (IQ-SPECT) |
| Date of disclosure of the study information | 2014/01/15 |
| Last modified on | 2014/01/14 17:09:17 |
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Basic information
Public title
Validation of nuclear myocardial perfusion imaging system using a multifocal collimator (IQ-SPECT)
Acronym
Validation of IQ-SPECT
Scientific Title
Validation of nuclear myocardial perfusion imaging system using a multifocal collimator (IQ-SPECT)
Scientific Title:Acronym
Validation of IQ-SPECT
Region
| Japan |
Condition
Condition
coronary artery disease, cardiomyopathy
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of images obtained with a multifocal collimator (IQ-SPECT) versus those acquired with a conventional collimator
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defect score, quantitative tracer uptake
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients undergo stress myocardial SPECT/CT imaging with IQ-SPECT and a conventional collimator.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are referred for stress myocardial SEPCT/CT and who can lie on their back for more than 15 minutes.
Key exclusion criteria
Patients in whom stress myocardial SPECT is contradindicated.
Patients who can not lie on their back for more than 15 minutes.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiko Morita |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Cardiology
Zip code
Address
18-1, Sakuradai, Minami-ku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
y-morita@sagamihara-hosp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Morita |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Cardiology
Zip code
Address
18-1, Sakuradai, Minami-ku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
Homepage URL
y-morita@sagamihara-hosp.or.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
国立病院機構相模原病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 17 | 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 | 01 | Month | 14 | Day |
Last modified on
| 2014 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011810
