UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013003 |
|---|---|
| Receipt number | R000015160 |
| Scientific Title | Quantifivation of myocardinal blood flow using 3-dimensional PET/CT system |
| Date of disclosure of the study information | 2014/01/30 |
| Last modified on | 2019/10/29 11:32:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Quantifivation of myocardinal blood flow using 3-dimensional PET/CT system
Acronym
Quantification of myocardinal blood flow using 3-dimensional PET/CT system
Scientific Title
Quantifivation of myocardinal blood flow using 3-dimensional PET/CT system
Scientific Title:Acronym
Quantification of myocardinal blood flow using 3-dimensional PET/CT system
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a method for quantification of myocardinal blood flow by using 15O-H2O and 3D PET-CT.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To estimate myocardinal blood flow at rest and durling stress.
Relationship between coronary flow reserve and coronary stenosis.
Key secondary outcomes
Relationship between CFR and clinical variables.
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
Healthy normal volunteers
1 Men and / or women, age equal to or greater than 20 years old
2 Written informed consent after explanation of the study procedures and risks.
Patients
In or out patients who are over 20 years old and were diagnosed as coronary artery disease (CAD) or suspected CAD, and give written informed consent for this study.
Key exclusion criteria
Patients / Volunteers
1. Patients with atrioventricular block
2. Patient of the bronchial asthma
3. Patients who are pregnant or who are at risk of pregnancy
4. Patients who did not agree with this study.
5. Patients deemed unsuitable by the principal investigator or investigator.
Volunteers
1. Patients with history of coronary arterial diseases.
2. Patients has the family of coronary artery disease of the under 55 years old onset.
3. Patients with a serious disease
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Nagara |
| Middle name | |
| Last name | Tamaki |
Organization
Hokkaido University, Graduate School of Medicine
Division name
Department of Nuclear Medicine
Zip code
060-8638
Address
N15 W7, Kita-Ku., Sapporo
TEL
011-706-5152
natamaki@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masanao |
| Middle name | |
| Last name | Naya |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
N15 W7 Kita-Ku Sapporo
TEL
011-716-1161
Homepage URL
nayamasanao@yahoo.co.jp
Sponsor or person
Institute
Hokkaido University, Graduate School of Medicine
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
Hokkaido University Hospital
Address
North 14, West 5, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2014 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
EJNMMI Res. 2017 Dec;7(1):52. doi: 10.1186/s13550-017-0296-x. Epub 2017 Jun 5.
Number of participants that the trial has enrolled
32
Results
Please see a paper above
Results date posted
| 2019 | Year | 10 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please see a paper above
Participant flow
Please see a paper above
Adverse events
Please see a paper above
Outcome measures
Please see a paper above
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2014 | Year | 01 | Month | 29 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015160
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
