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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006848
Receipt No. R000007560
Scientific Title Local pharmacologic MRA with nitroglycerin skin spray
Date of disclosure of the study information 2011/12/06
Last modified on 2019/04/24

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Basic information
Public title Local pharmacologic MRA with nitroglycerin skin spray
Acronym Local pharmacologic MRA with nitroglycerin
Scientific Title Local pharmacologic MRA with nitroglycerin skin spray
Scientific Title:Acronym Local pharmacologic MRA with nitroglycerin
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pilot study of non-enhanced MRA with nitroglycerin skin spray using upper extremities of healthy volunteers
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes We will compare the visibility of MRA using nitroglycerin skin spray in upper extremities using 5 score scale among three different groups of healthy volunteers: i.e. non-spray group, ipsilateral spray group and contralateral spray group, and confirm the usefulness of the nitroglycerin skin spray on pharmacologic MRA of upper extremities.
Key secondary outcomes We will evaluate side effects after spraying nitroglycerin.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 non-spray and nitroglycerin skin spray on ipsilateral brachail artery
Interventions/Control_2 non-spray and nitroglycerin skin spray on contralateral brachail artery
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
60 years-old >=
Gender Male and Female
Key inclusion criteria healthy adults
Key exclusion criteria coronary vessel disease
pregnant
renal dysfunction
during the administration of drugs
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keizo Tanitame
Organization Hiroshima University
Division name Department of Diagnostic Radiology
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keizo Tanitame
Organization Hiroshima University
Division name Department of Diagnostic Radiology
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Diagnostic Radiology, Hiroshima University
Institute
Department

Funding Source
Organization Department of Diagnostic Radiology, Hiroshima University
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
Email

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
2011 Year 12 Month 06 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
2011 Year 09 Month 19 Day
Date of IRB
2011 Year 09 Month 01 Day
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2012 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 12 Month 06 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007560

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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