UMIN-CTR Clinical Trial

Basic information
Public title	Dilatation effect of Nitroglycerin spray through the skin for superficial arteries: the evaluation using ultrasonography (Basic research for the usefulness of Nitroglycerin spray in superficial artery cannulation.)
Acronym	Local dilation effect of Nitroglycerin spray through the skin for superficial arteries.
Scientific Title	Dilatation effect of Nitroglycerin spray through the skin for superficial arteries: the evaluation using ultrasonography (Basic research for the usefulness of Nitroglycerin spray in superficial artery cannulation.)
Scientific Title:Acronym	Local dilation effect of Nitroglycerin spray through the skin for superficial arteries.
Region	Japan

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

Objectives
Narrative objectives1	We select 10 healthy volunteers randomly and evaluate the dilatation effect of Nitroglycerin spray through the skin for their brachial arteries using ultrasonography.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Local dilatation effect for brachial artery after skin spray of Nitroglycerin.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We measure the cross sectional areas of brachial arteries of 10 subjects before and after spraying Nitroglycerin to the upper skin of the arteries. The period of intervention for each volunteer is one hour.
Interventions/Control_2	We measure the cross sectional areas of brachial arteries of 10 subjects before and after spraying saline to the upper skin of the arteries. The period of intervention for each volunteer is one hour.
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	22 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy individuals
Key exclusion criteria	Individuals with vascular disease, hypotension, cardiac disease, renal hypofunction, primary pulmonary hypertension and abnormal laboratory data. Pregnant woman and possibly pregnant woman.
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kazuo Awai
Organization	Hiroshima University Hospital
Division name	Department of Diagnostic Radiology
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan
TEL
Email

Public contact
1st name of contact person	1st name Middle name Last name Keizo Tanitame
Organization	Hiroshima University Hospital
Division name	Department of Diagnostic Radiology
Zip code
Address
TEL
Homepage URL
Email	tntrad@ms1.megaegg.ne.jp

Sponsor
Institute	Department of Diagnostic Radiology, Hiroshima University Hospital
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
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	2010 Year 05 Month 01 Day
Date of IRB	2010 Year 04 Month 01 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2010 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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=R000004310