UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023337 |
|---|---|
| Receipt number | R000026724 |
| Scientific Title | 13N-Ammonia PET Assessment of Lower Extremity Perfusion in Peripheral Vascular Disease |
| Date of disclosure of the study information | 2016/07/30 |
| Last modified on | 2018/08/07 09:41:23 |
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Basic information
Public title
13N-Ammonia PET Assessment of Lower Extremity Perfusion in Peripheral Vascular Disease
Acronym
13N-Ammonia PET Assessment of Lower Extremity Perfusion in Peripheral Vascular Disease
Scientific Title
13N-Ammonia PET Assessment of Lower Extremity Perfusion in Peripheral Vascular Disease
Scientific Title:Acronym
13N-Ammonia PET Assessment of Lower Extremity Perfusion in Peripheral Vascular Disease
Region
| Japan |
Condition
Condition
Peripheral Vascular Disease
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the lower limb perfusion in PAD patients using 13N-ammonia PET/CT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ammonia PET was performed before and after medical treatment for patients with peripheral arterial occlusive disease , examine subjective symptoms , SPP, the correlation between ABI, TcPO2.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Ammonia PET/CT
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
1)patients undergoing ammmonia PET/CT before and after treatment
2)patients with peripheral arterial disease and volunteers agreeing with this study after informed concent
Key exclusion criteria
1. patients judged not eligible in this study
2. patients who have a serious underlying disease , a person who liver dysfunction , renal failure , or metabolic disorders are expected , performance status 4 .
3. patients with a history of hypersensitivity to ammonia
4. possibility of pregnancy.
5. regarded as unsuitable by investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yoko miyata |
Organization
National center for global health and medicine
Division name
Nuclear medicine
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
03-3202-7181
dyokomiyata@hospk.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yokomiyata |
Organization
National center for global health and medicine
Division name
Nuclear medicine
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
03-3202-7181
Homepage URL
dyokomiyata@hospk.ncgm.go.jp
Sponsor or person
Institute
National center for global health and medicine
Institute
Department
Personal name
Funding Source
Organization
National center for global health and medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 04 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 26 | Day |
Last modified on
| 2018 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026724
