UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	13N-Ammonia PET Assessment of Lower Extremity Perfusion in Peripheral Vascular Disease
Title of the study (Brief title)	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	yoko miyata
Organization	National center for global health and medicine
Division name	Nuclear medicine
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL	03-3202-7181
Email	dyokomiyata@hospk.ncgm.go.jp

Public contact
Name of contact person	yokomiyata
Organization	National center for global health and medicine
Division name	Nuclear medicine
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL	03-3202-7181
Homepage URL
Email	dyokomiyata@hospk.ncgm.go.jp

Sponsor
Institute	National center for global health and medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026724