UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000013003
Receipt No. 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 (Ver. 5)

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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
Email 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
Email nayamasanao@yahoo.co.jp

Sponsor
Institute Hokkaido University, Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015160