UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006847 |
|---|---|
| Receipt number | R000004310 |
| 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.) |
| Date of disclosure of the study information | 2011/12/06 |
| Last modified on | 2019/04/24 14:05:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Public contact
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
tntrad@ms1.megaegg.ne.jp
Sponsor or person
Institute
Department of Diagnostic Radiology, Hiroshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004310
